[Federal Register: August 9, 2010 (Volume 75, Number 152)]
[Notices]
[Page 48179-48233]
[DOCID:fr09au10-122]

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Part III

Department of Health and Human Services

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Food and Drug Administration

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Comprehensive List of Guidance Documents at the Food and Drug
Administration; Notice

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1998-N-0050] (formerly Docket No. 1998N-0046)

Comprehensive List of Guidance Documents at the Food and Drug
Administration

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is publishing a
comprehensive list of all guidance documents currently in use at the
agency. This list is being published under FDA's Good Guidance
Practices (GGPs). It is intended to inform the public of the existence
and availability of all of our current guidance documents. It also
provides information on guidance documents that have been added or
withdrawn in the past 5 years.

DATES:  We welcome general comments on this list and on agency guidance
documents at any time.

ADDRESSES:  Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
    For information on a specific guidance or to obtain a paper copy,
please refer to each Center's section of this document.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's GGPs were published in the Federal Register of September 19,
2000 (65 FR 56468), and became effective October 19, 2000. GGPs (21 CFR
10.115) are intended to ensure involvement of the public in the
development of guidance documents, and to enhance understanding of the
availability, nature, and legal effect of such guidance.
    FDA has adopted a new format for the publication of its
comprehensive guidance list. This new format is intended to increase
the timeliness of the comprehensive list. For information on a specific
guidance or to obtain a paper copy, please refer to each Center's
section of this document. The lists of guidance documents are either a
printout of FDA's Web site as of April 2010 or a list compiled by the
issuing office. You should note that some guidance documents pertain to
more than one product area (e.g., drugs and biologics), and are,
therefore, listed under both Centers involved or pertain to more than
one subject matter (e.g., ``Food Defense and Emergency Response'' and
``Imports''), and are, therefore, listed under more than one category
within a Center. So there may be some duplication in the guidance
lists. You are encouraged to use FDA's Web site as the most up-to-date
source for all current guidance documents in use by the agency, as the
Web site is updated on a daily basis.
    In accordance with the agency's general policy on guidances, you
may comment on this list and on any FDA guidance document at any time.
    We have organized the guidance documents by the issuing Center or
Office within FDA. The dates in the list refer to the date we issued
the guidances or, where applicable, the last date we revised a
document. Because each issuing Center or Office maintains its own
database, there are slight variations in the way in which they provide
the information.

II. Center for Biologics Evaluation and Research (CBER)

    For information a specific guidance document or to obtain a paper
copy, contact:
    Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-
1800, e-mail<EMAIL_ADDRESS>http://www.fda.gov/
BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/
Guidances/default.htm.
    The following is a list of CBER guidance documents that have been
withdrawn:

------------------------------------------------------------------------
                                              Date of         Date of
            Title of Document                 Issuance      Withdrawal
------------------------------------------------------------------------
Guidance for Industry: Gamma Irradiation   3/15/2000      4/10/2006
 of Blood and Blood Components: A Pilot
 Program for Licensing
------------------------------------------------------------------------
Draft Guidance for Industry: CBER Pilot    7/11/2001      4/11/2006
 Licensing Program for Immunization of
 Source Plasma Donors Using Immunogen Red
 Blood Cells Obtained from an Outside
 Supplier
------------------------------------------------------------------------
Draft Guidance for Industry: Submitting    8/23/2001      August 9,
 Type V Drug Master Files to the Center                    2010.
 for Biologics Evaluation and Research
------------------------------------------------------------------------

    The following list of current CBER guidance documents was obtained
from FDA's Web site on April 20, 2010:

Administrative
   Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments,
   and Proposed REMS Modifications (PDF - 316KB)
   9/2009
   Formal Meetings Between the FDA and Sponsors or Applicants (PDF - 89KB)
   5/2009
   Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific
   Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices
   1/2009
   Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties - Manufacturer's Notification of
   the Intent to Use an Accredited Person under the Accredited Persons Inspection Program Authorized by Section
   228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)
   9/15/2005

   Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The
   Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation
   Criteria
   10/4/2004
   Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions
   (510(k)s)
   5/28/2004
   FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock
   and Performance Assessment
   5/21/2004
   Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications
   11/24/2003
   Premarket Approval Application Modular Review
   11/3/2003
Adverse Events and Product Deviation Guidances
   Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs--Improving
   Human Subject Protection (PDF - 61KB)
   1/2009
   Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an
   Influenza Pandemic (PDF - 246KB)
   12/2008
   Providing Regulatory Submissions in Electronic Format--Postmarketing Individual Case Safety Reports
   (PDF - 107KB)
   6/2008
   Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of
   Biological Products Other than Blood and Blood Components
   10/2006
   Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products--Content
   and Format (PDF - 52KB)
   1/2006
   Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines (PDF -
   375KB)
   3/2001
   Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products:
   Clarification of What to Report (PDF - 95KB)
   8/1997
Allergenic Guidance Documents
   Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts
   11/20/2008
   Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A
   Revised Protocol
   11/20/2000
   Guidance for Industry On the Content and Format of Chemistry, Manufacturing and Controls Information
   and Establishment Description Information for an Allergenic Extract or Allergen Patch Test
   4/23/1999
Application Submissions
   Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug
   Products Terminally Sterilized by Moist Heat Processes (PDF - 73KB)
   2/2010
   SPL Standard for Content of Labeling Technical Qs & As (PDF - 58KB)
   10/2009
   Investigator Responsibilities--Protecting the Rights, Safety, and Welfare of Study Subjects (PDF -
   163KB)
   10/2009
   Providing Regulatory Submissions in Electronic Format--(PDF - 123KB)
   5/2009
   Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) -
   The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
   12/2008
   Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306KB)
   11/2008
   Tropical Disease Priority Review Vouchers (PDF - 112KB)
   10/2008
   Integrated Summary of Effectiveness (PDF - 95KB)
   8/2008
   Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA
   Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers (PDF Version) (PDF - 121KB)
   8/2008
   Providing Regulatory Submissions in Electronic Format--Postmarketing Individual Case Safety Reports
   (PDF - 107KB)
   6/2008
   Providing Regulatory Submissions in Electronic Format -Human Pharmaceutical Product Applications and
   Related Submissions Using the eCTD Specifications (PDF - 133KB)
   6/2008
   Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications
   (PMAs): Effect on FDA Review Clock and Goals (PDF Version) (PDF - 155KB)
   6/2008
   Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s,
   Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements (PDF Version) (PDF - 103KB)
   2/2008
   Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices (PDF
   Version) (PDF - 127KB)
   2/2008
   Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and
   Research (CBER) in Electronic Format - Lot Release Protocols (PDF - 76KB)
   11/2007

   In Vitro Diagnostic (IVD) Device Studies--Frequently Asked Questions (PDF - 268KB)
   10/2007
   Pharmacogenomic Data Submissions--Companion Guidance (PDF - 211KB)
   8/2007
   Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single
   Submission (PDF Version) (PDF - 145KB)
   6/2007
   Providing Regulatory Submissions in Electronic Format--Receipt Date (PDF - 59KB)
   6/2007
   Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval
   Applications (PMA) (PDF Version) (PDF - 127KB)
   10/2006
   Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (PDF
   Version) (PDF - 82KB)
   4/2006
   Reports on the Status of Postmarketing Study Commitments--Implementation of Section 130 of the Food
   and Drug Administration Modernization Act of 1997 (PDF - 456KB)
   2/2006
   Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PDF
   - 295KB)
   2/2006
   Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (PDF -
   110KB)
   2/2006
   Fast Track Drug Development Programs - Designation, Development, and Application Review (PDF - 83KB)
   2/2006
   How to Comply with the Pediatric Research Equity Act (PDF - 116KB)
   9/2005
   Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (PDF - 230KB)
   5/2005
   Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software
   Contained in Medical Devices (PDF version) (PDF - 342KB)
   5/2005
   Providing Regulatory Submissions in Electronic Format--Content of Labeling (PDF - 28KB)
   4/2005
   Good Review Management Principles and Practices for PDUFA Products (PDF - 683KB)
   4/2005
   Pharmacogenomic Data Submissions (PDF - 96KB)
   3/2005
   Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF
   - 211KB)
   12/2004
   Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical
   Device User Fees Under MDUFMA (PDF Version) (PDF - 97KB)
   11/2004
   Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The
   Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation
   Criteria (PDF Version) (PDF - 175KB)
   10/2004
   Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions
   (510(k)s) (PDF Version) (PDF - 109KB)
   5/2004
   Guidance for Industry and FDA Staff - FDA and Industry Actions on Premarket Notification (510(k))
   Submissions: Effect on FDA Review Clock and Performance Assessment (PDF Version) (PDF - 515KB)
   5/2004
   Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications (PDF
   Version) (PDF - 87KB)
   11/2003
   Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review (PDF Version) (PDF
   - 159KB)
   11/2003
   Providing Regulatory Submissions in Electronic Format - General Considerations (PDF - 288KB)
   10/2003
   Part 11, Electronic Records; Electronic Signatures--Scope and Application (PDF - 215KB)
   8/2003
   Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review (PDF Version) (PDF
    529KB)
   5/2003
   Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement
   Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products
   2/2003
   Comparability Protocols--Chemistry, Manufacturing, and Controls Information (PDF - 240KB)
   2/2003
   Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA
   Staff - PDF (PDF - 548KB)
   2/2003
   Special Protocol Assessment (PDF - 36KB)
   5/2002
   Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format--Investigational
   New Drug Applications (INDs) (PDF) (PDF - 80KB)
   3/2002
   Cancer Drug and Biological Products - Clinical Data in Marketing Applications (PDF - 39KB)
   10/2001
   Draft Guidance for Industry - Submitting Type V Drug Master Files to the Center for Biologics
   Evaluation and Research
   9/2001

   Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (PDF -
   50KB)
   8/2001
   Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (PDF -
   32KB)
   4/2001
   Acceptance of Foreign Clinical Studies (PDF - 12KB)
   3/2001
   Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (PDF - 56KB)
   11/2000
   Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26KB)
   10/2000
   Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic,
   Biotechnology-Derived Products (PDF - 14KB)
   10/2000
   Formal Meetings With Sponsors and Applicants for PDUFA Products (PDF - 30KB)
   2/2000
   Formal Dispute Resolution: Appeals Above the Division Level (PDF - 30KB)
   2/2000
   Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act
   (PDF - 57KB)
   9/1999
   Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (PDF - 43KB)
   8/1999
   Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in
   Electronic Format - Biologics Marketing Applications (PDF - 582KB)
   11/1999
   Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory
   Committees (PDF - 62KB)
   10/1998
   Submitting Debarment Certification Statements (PDF - 144KB)
   9/1998
   Standards for Prompt Review of Efficacy Supplements (PDF - 76KB)
   5/1998
   Classifying Resubmissions in Response to Action Letters (PDF - 76KB)
   4/1998
   Pediatric Use Supplements--Content and Format (PDF - 24KB)
   5/1996
   Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs (PDF
    41KB)
   11/1995
   Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs,
   Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB)
   11/1995
   FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and
   Manufacture of Biological Products; Availability (PDF - 34KB)
   7/1995
   Submission Documentation for Sterilization Process Validation in Applications for Human and
   Veterinary Drug Products (PDF - 57KB)
   11/1994
   Preparation of Investigational New Drug Products (Human and Animal) (PDF - 795KB)
   3/1991
   Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance
   with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration
   Amendments Act of 2007
Blood Guidance Documents
   Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood
   Components, October 2009 (PDF - 858KB)
   10/2009, Updated: 12/2009
   Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood
   Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus (PDF - 80KB)
   11/13/2009
   Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile
   Virus from Donors of Whole Blood and Blood Components Intended for Transfusion (PDF - 68KB)
   11/6/2009
   Draft Guidance for Industry and FDA Staff - Investigational New Drug Applications (INDs) for
   Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic
   Reconstitution for Specified Indications (PDF - 91KB)
   10/2009
   Guidance for Industry - Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood
   Intended for Hematopoietic Reconstitution for Specified Indications (PDF - 462KB)
   10/2009
   Guidance for Industry - Recommendations for Management of Donors at Increased Risk for Human
   Immunodeficiency Virus Type 1 (HIV-1) Group O Infection
   8/2009
   Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19
   Transmission by Plasma-Derived Products
   7/28/2009
   Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of
   Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and
   Cellular and Tissue-Based Products
   3/2009
   Assay Migration Studies for In Vitro Diagnostic Devices
   1/5/2009

   Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune
   Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
   7/17/2008
   Draft Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of
   Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)
   5/20/2008
   Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West
   Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human
   Cells, Tissues, and Cellular and Tissue-Based Products (HCT[sol]Ps)
   4/25/2008
   Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods
   12/17/2007
   Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood
   Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
   11/29/2007
   Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B
   Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source
   Plasma and Source Leukocytes
   11/21/2007
   Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility
   10/26/2007
   Guidance for Industry: ``Lookback'' for Hepatitis C Virus (HCV): Product Quarantine, Consignee
   Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor
   Test Results Indicating Infection with HCV
   8/24/2007
   Guidance for Industry: Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance
   Genotype Assay
   8/08/2007
   Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in
   Plasmapheresis and Immunization Programs
   6/20/2007
   Draft Guidance for Industry: ``Computer Crossmatch'' (Electronic Based Testing for the Compatibility
   between the Donor's Cell Type and the Recipient's Serum or Plasma Type)
   6/20/2007
   Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and
   Accompanying Materials for Use in Screening Donors of Blood and Blood Components
   10/27/2006
   Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments
   10/18/2006
   Guidance for Industry: Bar Code Label Requirements - Questions and Answers
   10/5/2006
   Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component
   Container Labels
   9/22/2006
   United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components
   Using ISBT 128 (PDF - 1665KB)
   9/22/2006
   Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease-
   Associated and Other Immunoglobulin (IgG) Antibodies
   8/08/2006
   Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to
   ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of
   Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products''
   8/08/2006
   Draft Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-
   1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
   7/19/2005
   Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of
   Known or Suspected West Nile Virus Infection
   6/23/2005
   Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor
   Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-
   Based Products (HCT[sol]Ps)
   11/24/2004
   Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
   11/30/2004
   Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as
   Red Blood Cell Substitutes
   10/28/2004
   Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of
   Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and
   Appropriately Reduce the Risk of Transmission of HIV-1 and HCV
   10/21/2004
   Questions and Answers on ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible
   Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood
   and Blood Products''
   1/22/2004
   Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of
   West Nile Virus - Guidance for Industry and FDA Staff
   10/30/2003
   Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion
   9/22/2003
   Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood
   Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS
   9/16/2003

   Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-
   Administered Questionnaires
   7/3/2003
   Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on
   Screening Tests for Syphilis
   6/25/2003
   Question and Answer on FDA Guidance Entitled ``Recommendations for the Assessment of Donor
   Suitability and Blood and Blood Product Safety in Cases of Suspected and Probable Severe Acute Respiratory
   Syndrome (SARS) or Exposure to SARS''
   4/25/2003
   Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product
   Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS
   4/17/2003
   Questions and Answers on FDA Guidance Entitled ``Recommendations for Deferral of Donors and
   Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia
   Virus) and Certain Contacts of Smallpox Vaccine Recipients''
   1/15/2003
   Guidance for Industry: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood
   and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox
   Vaccine Recipients
   12/30/2002
   Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of
   Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts
   2/1/2002
   General Principles of Software Validation; Final Guidance for Industry and FDA Staff
   1/11/2002
   Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of
   Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products
   1/9/2002
   Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices
   11/22/2001
   Guidance for Industry - Recommendations for Assessment of Donor Suitability and Blood and Blood
   Product Safety in Cases of Possible Exposure to Anthrax
   10/17/2001
   Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary
   Hemochromatosis
   8/22/2001
   Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood
   Components Intended for Transfusion or for Further Manufacture
   8/07/2001
   Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers
   7/19/2001
   Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile
   Connecting Devices)
   7/19/2001
   Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the
   Collection and Processing of Blood and Blood Components
   7/19/2001
   Guidance for Industry: Revised Recommendations Regarding Invalidation of Test Results of Licensed and
   510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors
   7/11/2001
   Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing
   3/29/2001
   Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods
    Technical Correction February 2001
   2/13/2001
   Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components
   Intended for Transfusion
   1/23/2001
   Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric
   Blood Specimens
   6/23/2000
   Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to
   Malaria
   6/8/2000
   Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of
   Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts
   12/23/1999
   Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic
   Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2
   12/14/1999
   Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug
   Regulations (PDF - 26KB)
   7/15/1999
   Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured
   for Commercial Use
   5/20/1999
   Draft Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products
   5/20/1999
   Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment
   Description Information for Human Blood and Blood Components Intended for Transfusion or for Further
   Manufacture and For the Completion of the Form FDA 356h ``Application to Market a New Drug, Biologic or an
   Antibiotic Drug for Human Use''
   5/10/1999
   Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and
   Establishment Description Information for a Biological In Vitro Diagnostic Product
   3/8/1999

   Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment
   Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products
   2/17/1999
   Withdrawal of ``Guidance for Industry: Supplemental Testing and the Notification of Consignees of
   Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)''
   9/8/1998
   Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral
   Marker Testing
   6/11/1998
   Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results
   for Antibody to Hepatitis C Virus (Anti-HCV)
   3/20/1998
   Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in
   the Manufacture of Blood Products
   1/08/1998
   Guidance for Industry: Donor Screening for Antibodies to HTLV-II
   8/15/1997
   Guidance for Industry: Changes to an Approved Application: Biological Products (PDF - 39KB)
   7/1997
   Guideline for Quality Assurance in Blood Establishments (PDF - 77KB)
   7/11/1995
   Draft Recommended Methods for Blood Grouping Reagents Evaluation (PDF - 2101KB)
   3/1992
   Draft Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin
   (PDF - 1161KB)
   3/1992
   Draft Points to Consider in the Design and Implementation of Field Trials for Blood Grouping Reagents
   and Anti-Human Globulin (PDF - 211KB)
   1992
   Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious
   Disease Markers (``High Risk'' Donors) (PDF - 176KB)
   10/26/1989
   Draft Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect
   Antibodies to the Human Immunodeficiency Virus Type 1 (PDF - 1784KB)
   8/08/1989
   Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For
   Human and Animal Parenteral Drugs, Biological Products and Medical Devices (PDF - 2874KB)
   12/1987
   Guideline for the Uniform Labeling of Blood and Blood Components (PDF - 1189KB)
   8/1985
   Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances (PDF - 368KB)
   6/1980
Cellular & Gene Therapy Guidance Documents
   Draft Guidance for Industry and FDA Staff - Investigational New Drug Applications (INDs) for
   Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic
   Reconstitution for Specified Indications (PDF - 91KB)
   10/2009
   Guidance for Industry - Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood
   Intended for Hematopoietic Reconstitution for Specified Indications (PDF - 462KB)
   10/2009
   Draft Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines
   9/2009
   Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
   09/2009
   Draft Guidance for Industry: Somatic Cell Therapy for Cardiac Disease
   03/2009
   Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products
   10/9/2008
   Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control
   (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
   4/9/2008
   Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control
   (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
   4/9/2008
   Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility
   Testing of Cellular and Gene Therapy Products
   2/11/2008
   Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and
   Tissue-Based Products
   8/8/2007
   Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace
   Knee Cartilage
   7/6/2007
   Guidance for Industry: Gene Therapy Clinical Trials - Observing Subjects for Delayed Adverse Events
   11/28/2006
   Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in
   Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using
   Retroviral Vectors
   11/28/2006
   Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy
   3/30/1998

   Guidance for the Submission of Chemistry, Manufacturing, and Controls Information and Establishment
   Description for Autologous Somatic Cell Therapy Products (TXT - 59KB)
   01/1997
CMC & GMP
   Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug
   Products Terminally Sterilized by Moist Heat Processes (PDF - 73KB)
   2/2010
   Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics (PDF - 91KB)
   11/2008
   Process Validation: General Principles and Practices (PDF - 194KB)
   11/2008
   Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF - 132KB)
   7/2008
   Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using
   Spore-Forming Microorganisms (PDF - 184KB)
   9/6/2007
   Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF -
   443KB)
   9/2006
   Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling (PDF
    253KB)
   9/2006
   Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (PDF -
   110KB)
   1/2006
   Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (PDF - 230KB)
   5/2005
   Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing Practice (PDF -
   734KB)
   9/2004
   Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing,
   and Controls Information (PDF - 82KB)
   9/2003
   Comparability Protocols--Chemistry, Manufacturing, and Controls Information (PDF - 240KB)
   2/2003
   CVM GFI 153 Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use
   in Humans and Animals (PDF - 88KB)
   9/2002
   Container Closure Systems for Packaging Human Drugs and Biologics--Questions and Answers (PDF - 15KB)
   5/2002
   IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (PDF -
   30KB)
   5/2001
   Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing (PDF - 30KB)
   3/2001
   Analytical Procedures and Methods Validation Chemistry, Manufacturing, and Controls Documentation
   (PDF - 91KB)
   8/2000
   Possible Dioxin/PCB Contamination of Drug and Biological Products (PDF - 8KB)
   8/1999
   Container Closure Systems for Packaging Human Drugs and Biologics (PDF - 164KB)
   5/1999
   Environmental Assessment of Human Drug and Biologics Applications (PDF - 188KB)
   7/1998
   Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (PDF - 150KB)
   3/1998
   Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a
   Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use (PDF - 44KB)
   8/1996
   Submission Documentation for Sterilization Process Validation in Applications for Human and
   Veterinary Drug Products (PDF - 57KB)
   11/1994
   Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For
   Human and Animal Parenteral Drugs, Biological Products and Medical Devices (PDF - 2874KB)
   12/1987
   Guidance on Alternatives to Lot Release for Licensed Biological Products (PDF - 305KB)
   7/14/1993
Clinical
   Drug-Induced Liver Injury: Premarketing Clinical Evaluation (PDF - 206KB)
   7/2009
   Postmarketing Studies and Clinical Trials--Implementation of Section 505(o) of the Federal Food,
   Drug, and Cosmetic Act (PDF - 173KB)
   7/2009
   The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug
   Application (PDF - 421KB)
   6/2009
   Animal Models--Essential Elements to Address Efficacy Under the Animal Rule (PDF - 135KB)
   2/2009
   Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs--Improving
   Human Subject Protection (PDF - 61KB)
   1/2009
   Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (PDF - 145KB)
   5/2007
   Computerized Systems Used in Clinical Trials (PDF - 53KB)
   5/2007

   Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling (PDF
    253KB)
   9/2006
   Chronic Cutaneous Ulcer and Burn Wounds--Developing Products for Treatment (PDF - 205KB)
   6/2006
   Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens
   that are Not Individually Identifiable (PDF Version) (PDF - 65KB)
   4/25/2006
   The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial
   Sponsors
   3/2006
   Using a Centralized IRB Review Process in Multicenter Clinical Trials (PDF - 87KB)
   3/2006
   Reports on the Status of Postmarketing Study Commitments--Implementation of Section 130 of the Food
   and Drug Administration Modernization Act of 1997 (PDF - 456KB)
   2/2006
   Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products--Content and
   Format (PDF - 127KB)
   2/2006
   Collection of Race and Ethnicity Data in Clinical Trials (PDF - 70KB)
   9/2005
   Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult
   Healthy Volunteers (PDF - 702KB)
   7/2005
   Evaluating the Risks of Drug Exposure in Human Pregnancies (PDF - 3151KB)
   4/2005
   Premarketing Risk Assessment (PDF - 88KB)
   3/2005
   Development and Use of Risk Minimization Action Plans (PDF - 225KB)
   3/2005
   Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (PDF - 220KB)
   3/2005
   Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling (PDF -
   363KB)
   2/2005
   Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF
   - 211KB)
   12/2004
   Available Therapy (PDF - 176KB)
   7/2004
   Vaccinia Virus--Developing Drugs to Mitigate Complications from Smallpox Vaccination (PDF - 139KB)
   3/2004
   Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF -
   40KB)
   1/2004
   IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of
   Cancer (PDF - 188KB)
   1/2004
   Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices (PDF Version)
   (PDF - 389KB)
   7/2003
   Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact
   on Dosing and Labeling (PDF - 222KB)
   5/2003
   Exposure-Response Relationships--Study Design, Data Analysis, and Regulatory Applications (PDF -
   221KB)
   4/2003
   Establishing Pregnancy Exposure Registries (PDF - 268KB)
   8/2002
   Special Protocol Assessment (PDF - 36KB)
   5/2002
   FDA Guidance on Clinical Trial Data Monitoring Committees (DMC's) Open Public Meeting (PDF - 394KB)
   11/2001
   Cancer Drug and Biological Products - Clinical Data in Marketing Applications (PDF - 39KB)
   10/2001
   IDE Financial Disclosure
   Acceptance of Foreign Clinical Studies (PDF - 12KB)
   3/2001
   Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (PDF - 56KB)
   11/2000
   Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26KB)
   10/2000
   Pediatric Oncology Studies In Response to a Written Request (PDF - 30KB)
   6/2000
   In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations
   for Dosing and Labeling (PDF - 44KB)
   11/2009
   Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment
   of Osteoarthritis (PDF - 40KB)
   7/1999
   Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of
   Rheumatoid Arthritis (RA) (PDF - 369KB)
   2/1999
   Population Pharmacokinetics (PDF - 135KB)
   2/1999
   FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (PDF - 58KB)
   12/1998

   General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products (PDF -
   37KB)
   11/1998
   Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (PDF - 129KB)
   5/1998
   Pharmacokinetics in Patients with Impaired Renal Function (PDF - 128KB)
   5/1998
   Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs,
   Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB)
   11/1995
Devices
   Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (PDF Version) (PDF -
   388KB)
   Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The
   Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation
   Criteria (PDF Version) (PDF - 175KB)
   Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions
   (510(k)s) (PDF Version) (PDF - 109KB)
   Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and
   Biological Products (PDF - 112KB)
   Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) -
   The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
   Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) -
   The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
   Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications
   (PMAs): Effect on FDA Review Clock and Goals (PDF Version) (PDF - 155KB)
   Guidance for Industry and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and
   Answers (PDF Version) (PDF - 196KB)
   Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s,
   Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements (PDF Version) (PDF - 103KB)
   Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices (PDF
   Version) (PDF - 127KB)
   In Vitro Diagnostic (IVD) Device Studies--Frequently Asked Questions (PDF - 268KB)
   Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions (PDF Version)
   (PDF - 139KB)
   In Vitro Diagnostic Multivariate Index Assays (PDF version) (PDF - 72KB)
   Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single
   Submission (PDF Version) (PDF - 145KB)
   Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval
   Applications (PMA) (PDF Version) (PDF - 127KB)
   Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software
   Contained in Medical Devices (PDF version) (PDF - 342KB)
   Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products--Content and
   Format (PDF - 127KB)
   Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens
   that are Not Individually Identifiable (PDF Version) (PDF - 65KB)
   Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (PDF
   Version) (PDF - 82KB)
   Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
   Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical
   Device User Fees Under MDUFMA (PDF Version) (PDF - 97KB)
   Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices (PDF Version)
   (PDF - 389KB)
   Guidance for Industry and FDA Staff - FDA and Industry Actions on Premarket Notification (510(k))
   Submissions: Effect on FDA Review Clock and Performance Assessment (PDF Version) (PDF - 515KB)
   Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review (PDF Version) (PDF
   - 159KB)
   Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review (PDF Version) (PDF
    529KB)
   Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement
   Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products
   Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA
   Staff - PDF (PDF - 548KB)
   Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The
   Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation
   Criteria (PDF Version) (PDF - 175KB)
Labeling & Promotion
   Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug
   and Biological Products (PDF - 163KB)
   Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306KB)
   Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PDF
   - 295KB)
   Labeling for Human Prescription Drug and Biological Products--Determining Established Pharmacologic
   Class for Use in the Highlights of Prescribing Information (PDF - 65KB)
   Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 387KB)
   Indexing Structured Product Labeling (PDF - 59KB)
   Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions (PDF Version)
   (PDF - 139KB)
   Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products--Content
   and Format (PDF - 52KB)
   Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products--Content and
   Format (PDF - 127KB)
   Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human
   Prescription Drug and Biological Products--Content and Format (PDF - 58KB)
   Labeling for Human Prescription Drug and Biological Products--Implementing the New Content and Format
   Requirements (PDF - 213KB)
   Providing Regulatory Submissions in Electronic Format--Content of Labeling (PDF - 28KB)
   Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling (PDF -
   363KB)
   Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic
   Devices Intended for Professional Use (PDF Version) (PDF - 1385KB)
   Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (PDF - 192KB)
   ``Help-Seeking'' and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms
   (PDF - 188KB)
   Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact
   on Dosing and Labeling (PDF - 222KB)

   Content and Format for Geriatric Labeling (PDF - 38KB)
   Prescription Drug Advertising and Promotional Labeling (PDF - 28KB)
   In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations
   for Dosing and Labeling (PDF - 44KB)
   Consumer-Directed Broadcast Advertisements (PDF - 36KB)
   Accelerated Approval Products--Submission of Promotional Materials (PDF - 17KB)
   Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 86KB)
   Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 -
   Elimination of Certain Labeling Requirements (PDF - 979KB)
Tissue Guidance Documents
   Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of
   Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and
   Cellular and Tissue-Based Products
   3/2009
   Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for
   Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT[sol]Ps)
   1/16/2009
   Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
   (HCT[sol]Ps) - Small Entity Compliance Guide
   8/24/2007
   Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace
   Knee Cartilage
   7/6/2007
   Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update
   9/20/2006
   Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for
   Transplantation
   3/8/2002
   Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West
   Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human
   Cells, Tissues, and Cellular and Tissue-Based Products (HCT[sol]Ps)
   4/25/2008
   Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products
   (HCT[sol]Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or
   Diagnostic Tests
   4/16/2008
   Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and
   Tissue-Based Products
   8/8/2007
   Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor
   Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-
   Based Products (HCT[sol]Ps)
   11/12/2004
   Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric
   Blood Specimens
   6/23/2000
   Guidance for Industry: Compliance with 21 CFR Part 1271.150(c)(1)--Manufacturing Arrangements
   9/8/2006
   Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to
   Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT[sol]Ps)
   11/30/2005
   Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally
   Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
   7/23/2007
   Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and
   Storage Container
   1/31/2007
   Draft Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord
   Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
   1/16/2007
   Guidance for Industry: Screening and Testing of Donors of Human Tissue Intended for Transplantation
   (PDF - 59KB)
Vaccine Guidance Documents
   Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological
   Materials Used in the Production of Viral Vaccines for Infectious Disease Indications (PDF - 406KB)
   3/2010
   Draft Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines
   09/2009
   Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global
   Infectious Diseases
   9/8/2008
   Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
   10/29/2007
   Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in
   Preventive Vaccine Clinical Trials
   9/27/2007
   Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
   5/31/2007
   Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated
   Influenza Vaccines
   5/31/2007
   Draft Guidance for Industry: Characterization and Qualification of Cell Substrates and Other
   Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of
   Infectious Diseases
   9/28/2006
   Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations
   5/4/2006
   Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and
   Therapeutic Vaccines for Infectious Disease Indications
   2/13/2006

   Draft Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease
   Indications
   2/17/2005
   Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions,
   and Precautionary Information
   10/1/2004
   Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products
   Including Vaccines
   3/12/2001
   Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A
   Revised Protocol
   11/20/2000
   Draft Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines
   for Infectious Disease Indications
   9/8/2000
   Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and
   Establishment Description Information for a Vaccine or Related Product
   1/5/1999
   Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1) (PDF
   - 63KB)
   9/8/1998
   Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases:
   Production, Testing and Clinical Studies (PDF - 49KB)
   4/10/1997
Xenotransplantation Guidance Documents
   Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of
   Xenotransplantation Products in Humans
   4/3/2003
   Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of
   Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts
   2/1/2002
   Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of
   Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts
   12/23/1999
   PHS Guideline on Infectious Disease Issues in Xenotransplantation
   1/19/2001
   Guidance For Industry: Public Health Issues Posed by the Use of Non-Human Primate Xenografts in
   Humans
   4/6/1999

III. Center for Drug Evaluation and Research (CDER)

    For information on a specific guidance document or to obtain a
paper copy, contact:
    Division of Drug Information, Office of Training and
Communications, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver
Spring, MD 20993, 1-888-463-6332 or<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/default.htm.
    The following list of withdrawn CDER guidance documents was
obtained from FDA's Web site on April 21, 2010:

----------------------------------------------------------------------------------------------------------------
                                                               Level at Date     Publication/
                  Title                         Subject          of Issue       Withdrawal Date       Status
----------------------------------------------------------------------------------------------------------------
Continuous Marketing Applications: Pilot  Procedural          Level 1         04/09/2010          Withdrawn
 1--Reviewable Units for Fast Track
 Products under PDUFA
----------------------------------------------------------------------------------------------------------------
Continuous Marketing Applications: Pilot  Procedural          Level 1         04/09/2010          Withdrawn
 2--Scientific Feedback and Interactions
 during Development of Fast Track
 Products under PDUFA
----------------------------------------------------------------------------------------------------------------
Continuous Marketing Applications: Pilot  Procedural          Level 1         04/09/2010          Withdrawn
 2--Scientific Feedback and Interactions
 during Development of Fast Track
 Products under PDUFA; Paperwork
 Reduction Act Burden Statement
----------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Lipid-Altering     Clinical Medical    Level 1         04/16/2010          Withdrawn
 Agents                                    Draft
----------------------------------------------------------------------------------------------------------------

    The following list of current CDER guidance documents was obtained
from FDA's Web site on April 21, 2010:

------------------------------------------------------------------------
                                                                 Issue
                  Title and Format                      Type      Date
------------------------------------------------------------------------
Advertising
Accelerated Approval Products: Submission of          Draft    3/26/1999
 Promotional Materials (PDF - 17 KB)
Aerosol Steroid Product Safety Information in         Final    12/1997
 Prescription Drug Advertising and Promotional
 Labeling (PDF - 84 KB)
Brief Summary: Disclosing Risk Information in         Draft    2/4/2004
 Consumer-Directed Print Advertisements (PDF - 192
 KB)
   Labeling Example (PDF - 105 KB)            .......  .........
   Labeling Example; Consumer-Friendly        .......  .........
   Version (PDF - 95KB)

Consumer-Directed Broadcast Advertisements (PDF -     Final    8/1999
 36KB)
Questions and Answers (PDF - 83 KB)
Consumer-Directed Broadcast Advertising of            Draft    1/26/2004
 Restricted Devices (PDF - 41 KB)
``Help-Seeking'' and Other Disease Awareness          Draft    1/26/2004
 Communications by or on Behalf of Drug and Device
 Firms (PDF - 188 KB)
Industry-Supported Scientific and Educational         Final    12/3/1997
 Activities (PDF - 429 KB)
Presenting Risk Information in Prescription Drug and  Draft    5/26/2009
 Medical Device Promotion (PDF - 387 KB)
Product Name Placement, Size, and Prominence in       Draft    1/1999
 Advertising and Promotional Labeling (PDF - 86KB)
Biopharmaceutics
Bioanalytical Method Validation (PDF - 63 KB)         Final    5/2001
Bioavailability and Bioequivalence Studies for Nasal  Draft    4/2/2003
 Aerosols and Nasal Sprays for Local Action (PDF -             4/11/2003
 519 KB)
   Statistical Information from the June      .......  .........
   1999 Draft Guidance and Statistical Information
   for In Vitro Bioequivalence Data (PDF - 186 KB)
Bioavailability and Bioequivalence Studies for        Final    3/2003
 Orally Administered Drug Products - General
 Considerations (PDF - 268 KB)
Cholestyramine Powder in Vitro Bioequivalence (PDF -  Final    7/15/93
 35 KB) (Intermin Guidance)
Clozapine Tablets: In Vivo Bioequivalence and In      Final    6/17/2005
 Vitro Dissolution Testing (PDF - 78 KB)
Conjugated Estrogens, USP-LC-MS Method for Both       Draft    8/12/2005
 Qualitative Chemical Characterization and            Withdra
 Documentation of Qualitative Pharmaceutical           wn
 Equivalence.                                         FR
                                                       Notice
Corticosteroids, Dermatologic (topical) In Vivo (PDF  Final    6/2/1995
 - 3 MB) (Issued 6/2/1995, Posted 3/6/1998)
Dissolution Testing of Immediate Release Solid Oral   Final    8/1997
 Dosage Forms (PDF - 130 KB) (Issued 8/1997, Posted
 8/25/1997)
Extended Release Oral Dosage Forms: Development,      Final    9/1997
 Evaluation, and Application of In Vitro/In Vivo
 Correlations (PDF - 170 KB)
Food-Effect Bioavailability and Fed Bioequivalence    Final    12/2002
 Studies(PDF - 166 KB)
Metaproterenol Sulfate and Albuterol Metered Dose     Final    6/27/1989
 Inhalers In Vitro (PDF - 744 KB)
Potassium Chloride (slow-release tablets and          Final    6/6/1994
 capsules) In Vivo Bioequivalence and In Vitro
 Dissolution Testing (PDF - 718 KB)
Statistical Approaches to Establishing                Final    2/2001
 Bioequivalence (PDF - 130 KB)
Waiver of In Vivo Bioavailability and Bioequivalence  Final    8/2000
 Studies for Immediate-Release Solid Oral Dosage
 Forms Based on a Biopharmaceutics Classification
 System.(PDF - 143 KB).
CMC - Microbiology (Chemistry, Manufacturing, and Controls)
Submission Documentation for Sterilization Process    Final    11/1994
 Validation in Applications for Human and Veterinary
 Drug Products (PDF - 57 KB)
Submission of Documentation in Applications for       Final    2/25/2010
 Parametric Release of Human and Veterinary Drug
 Products Terminally Sterilized by Moist Heat
 Processes (PDF - 76 KB)
Chemistry, Manufacturing, and Controls (CMC)
Analytical Procedures and Methods Validation.(PDF -   Draft    8/2000
 91 KB)
Assay Development for Immunogenicity Testing of       Draft    12/3/2009
 Therapeutic Proteins (PDF - 161 KB)
BACPAC I: Intermediates in Drug Substance Synthesis;  Final    Withdrawn
 Bulk Actives Postapproval Changes: Chemistry,                  as per
 Manufacturing, and Controls Documentation 2/2001               FR
                                                                notice
                                                                June 1,
                                                                2006
Botanical Drug Products (PDF - 437 KB)                Final    6/2004
Changes to an Approved Application for Specified      Final    7/1997
 Biotechnology and Specified Synthetic Biological
 Products (PDF - 33 KB)
Changes to an Approved NDA or ANDA (PDF - 108 KB)     Final    4/2004
Changes to an Approved NDA or ANDA: Questions and     Final    1/2001
 Answers (PDF - 35 KB)
Changes to an Approved NDA or ANDA; Specifications--  Final    11/19/
 Use of Enforcement Discretion for Compendial                   2004
 Changes (PDF - 18 KB)
Comparability Protocols--Chemistry, Manufacturing,    Draft    2/2003
 and Controls Information (PDF - 240 KB)
Container Closure Systems for Packaging Human Drugs   Final    5/1999
 and Biologics (PDF - 164 KB)
   [Container Closure Systems for Packaging   .......  5/2002
   Human Drugs and Biologics--Questions and Answers
   (PDF - 15 KB)
Demonstration of Comparability of Human Biological    Final    4/1996
 Products, Including Therapeutic Biotechnology-
 derived Products
Development of New Stereoisomeric Drugs               Final    5/1/1992
Drug Master Files                                     Final    9/1/1989
 Current DMF Information(e.g. lists, addresses,
 guidances, etc.)
Drug Master Files for Bulk Antibiotic Drug            Final    11/1999
 Substances (PDF - 23 KB)
Drug Product: Chemistry, Manufacturing, and Controls  Draft    Withdrawn
 Information 1/2003                                             as per
                                                                FR
                                                                notice
                                                                June 1,
                                                                2006
Drug Substance: Chemistry, Manufacturing, and         Draft    Withdrawn
 Controls Information 1/2004                                    as per
                                                                FR
                                                                notice
                                                                June 1,
                                                                2006
Drugs, Biologics, and Medical Devices Derived from    Draft    9/11/2003
 Bioengineered Plants for Use in Humans and Animals
 (PDF - 88 KB)
Environmental Assessment of Human Drug and Biologics  Final    7/1998
 Applications (PDF - 188 KB)
Format and Content of the Chemistry, Manufacturing    Final    Withdrawn
 and Controls Section of an Application* 2/1987                 as per
                                                                FR
                                                                notice
                                                                June 1,
                                                                2006
Format and Content for the CMC Section of an Annual   Final    9/1/1994
 Report (PDF - 29 KB)

Incorporation of Physical-Chemical Identifiers into   Draft    7/13/2009
 Solid Oral Dosage Form Drug Products for
 Anticounterfeiting (PDF - 79 KB)
INDs for Phase 2 and Phase 3 Studies Chemistry,       Final    5/20/2003
 Manufacturing, and Controls Information (PDF - 193
 KB)
IND Meetings for Human Drugs and Biologics            Final    5/2001
 Chemistry, Manufacturing, and Controls Information
 (PDF - 30 KB)
Interpreting Sameness of Monoclonal Antibody          Draft    7/24/1999
 Products Under the Orphan Drug Regulations (PDF -
 26 KB)
Liposome Drug Products: Chemistry, Manufacturing,     Draft    7/2002
 and Controls; Human Pharmacokinetics and
 Bioavailability; and Labeling Documentation.(PDF -
 45 KB)
Monoclonal Antibodies Used as Reagents in Drug        Final    3/2001
 Manufacturing (PDF - 29 KB)
Metered Dose Inhaler (MDI) and Dry Powder Inhaler     Draft    11/13/
 (DPI) Drug Products (PDF - 361 KB)                             1998
Nasal Spray and Inhalation Solution, Suspension, and  Final    7/2002
 Drug Products (PDF - 116 KB)
NDAs: Impurities in Drug Substances (PDF - 11 KB)     Final    2/2000
Orally Disintegrating Tablets (PDF - 52 KB)           Final    12/17/
                                                                2008
PAC-ATLS: Postapproval Changes - Analytical Testing   Final    4/28/1998
 Laboratory Sites (PDF - 76 KB)
Residual Solvents in Drug Products Marketed in the    Final    11/24/
 United States (PDF - 52 KB)                                    2009
Reviewer Guidance, Validation of Chromatographic      Final    11/1994
 Methods (PDF - 703 KB) (revised to include
 graphics, 5/14/2007)
The Sourcing and Processing of Gelatin to Reduce the  Final    12/20/
 Potential Risk Posed by Bovine Spongiform                      2000
 Encephalopathy (BSE)(PDF - 790 KB)
Stability Testing of Drug Substances and Drug         Draft    Withdrawn
 Products 6/5/1998                                              as per
                                                                FR
                                                                notice
                                                                June 1,
                                                                2006
Submission of Chemistry, Manufacturing, and Controls  Final    Withdrawn
 Information for Synthetic Peptide Substances 11/               as per
 1994                                                           FR
                                                                notice
                                                                June 1,
                                                                2006
Submitting Documentation for the Manufacturing of     Final    2/1987
 and Controls for Drug Products*(PDF - 1.02 MB)
Submitting Documentation for the Stability of Human   Final    Withdrawn
 Drugs and Biologics* (Issued , Posted 3/2/1998)                as per
                                                                FR
                                                                notice
                                                                June 1,
                                                                2006
Submitting Samples and Analytical Data for Methods    Final    2/1987
 Validation
Submitting Supporting Documentation in Drug           Final    2/1987
 Applications for the Manufacture of Drug Substances
 (PDF - 94 KB)
SUPAC-IR: Immediate-Release Solid Oral Dosage Forms:  Final    11/1995
 Scale-Up and Post-Approval Changes: Chemistry,
 Manufacturing and Controls, In Vitro Dissolution
 Testing, and In Vivo Bioequivalence Documentation
 (PDF - 60 KB)
SUPAC-IR Questions and Answers about SUPAC-IR         Final    2/18/1997
 Guidance
SUPAC-IR/MR: Immediate Release and Modified Release   Final    1/1999
 Solid Oral Dosage Forms Manufacturing Equipment
 Addendum (PDF - 117 KB)
SUPAC-MR: Modified Release Solid Oral Dosage Forms    Final    Issued 10/
 Scale-Up and Postapproval Changes: Chemistry,                  6/1997
 Manufacturing, and Controls; In Vitro Dissolution
 Testing and In Vivo Bioequivalence Documentation
 (PDF - 215 KB)
SUPAC-SS: Nonsterile Semisolid Dosage Forms           Draft    12/1998
 Manufacturing Equipment Addendum (PDF - 61 KB)
SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-   Final    5/1997
 Up and Post-Approval Changes: Chemistry,
 Manufacturing and Controls; In Vitro Release
 Testing and In Vivo Bioequivalence Documentation
 (PDF - 118 KB)
Clinical / Antimicrobial
Acute Bacterial Exacerbations of Chronic Bronchitis   Draft    8/21/2008
 in Patients with Chronic Obstructive Pulmonary
 Disease: Developing Antimicrobial Drugs for
 Treatment(PDF - 422 KB)
Acute Bacterial Meningitis--Developing Antimicrobial  Draft    7/22/1998
 Drugs for Treatment(PDF - 42 KB)
Acute Bacterial Sinusitis--Developing Antimicrobial   Draft    10/29/
 Drugs for Treatment (PDF - 155 KB)                             2007
Acute or Chronic Bacterial Prostatitis--Developing    Draft    7/22/1998
 Antimicrobial Drugs for Treatment (PDF - 42 KB)
Acute Bacterial Otitis Media: Developing Drugs for    Draft    1/17/2008
 Treatment (PDF - 173 KB)
Antibacterial Drug Products: Use of Noninferiority    Draft    10/12/
 Studies to Support Approval (PDF - 41 KB)                      2007
Antiviral Product Development--Conducting and         Final    6/2/2006
 Submitting Virology Studies to the Agency (PDF -
 208 KB)
   Guidance for Submitting HIV Resistance     .......  .........
   Data (PDF - 293 KB)
   Guidance for Submitting Influenza          .......  .........
   Resistance Data (PDF - 385 KB)
   Guidance for Submitting HBV Resistance     .......  .........
   Data (PDF - 123 KB)
   Guidance for Submitting HCV Resistance     .......  .........
   Data (PDF - 122 KB)
Antiretroviral Drugs Using Plasma HIV RNA             Final    10/2002
 Measurements--Clinical Considerations for
 Accelerated and Traditional Approval (PDF - 254 KB)
Bacterial Vaginosis--Developing Antimicrobial Drugs   Draft    7/22/1998
 for Treatment (PDF - 53 KB)
Catheter-Related Bloodstream Infections - Developing  Draft    10/1999
 Antimicrobial Drugs for Treatment (PDF - 54 KB)
Clinical Development and Labeling of Anti-Infective   Final    10/1992
 Drug Products (PDF - 5 MB)                                     Revised
                                                                2/12/
                                                                2001
Clinical Evaluation of Anti-Infective Drugs           Final    9/77
 (Systemic)(PDF - 1 MB)
Community-Acquired Bacterial Pneumonia: Developing    Draft    3/19/2009
 Drugs for Treatment (PDF - 418 KB)
Complicated Urinary Tract Infections and              Draft    7/22/1998
 Pyelonephritis--Developing Antimicrobial Drugs for
 Treatment (PDF - 35 KB)
Developing Antimicrobial Drugs--General               Draft    7/22/1998
 Considerations for Clinical Trials (PDF - 134 KB)
 [Main Document]
Developing Antimicrobial Drugs to Treat Inhalational  Draft    3/15/2002
 Anthrax (Post Exposure)--(PDF - 51 KB)
Empiric Therapy of Febrile Neutropenia--Developing    Draft    7/22/1998
 Antimicrobial Drugs for Treatment (PDF - 33 KB)
Evaluating Clinical Studies Of Antimicrobials In The  Draft    2/18/1997
 Division Of Anti-Infective Drug Products (PDF - 267
 KB)

Helicobacter pylori-Associated Duodenal Ulcer         Draft    10/2/2009
 Disease in Adults: Developing Drugs for Treatment
 (PDF - 145 KB)
Influenza: Developing Drugs for Treatment and/or      Draft    2/19/2009
 Prophylaxis(PDF - 225 KB)
Lyme Disease--Developing Antimicrobial Drugs for      Draft    7/22/1998
 Treatment (PDF - 42 KB)
Microbiological Data for Systemic Antibacterial Drug  Draft    9/16/2009
 Products--Development, Analysis, and Presentation
 (PDF - 272 KB)
Nosocomial Pneumonia--Developing Antimicrobial Drugs  Draft    7/22/1998
 for Treatment (PDF - 49 KB)
Role of HIV Drug Resistance Testing in                Final    10/30/
 Antiretroviral Drug Development (PDF - 244 KB)                 2007
Secondary Bacterial Infections of Acute Bronchitis--  Draft    7/22/1998
 Developing Antimicrobial Drugs for Treatment (PDF -
 10 KB)
Smallpox (Variola) Infection: Developing Drugs for    Draft    11/21/
 Treatment or Prevention (PDF - 257 KB)                         2007
Streptococcal Pharyngitis and Tonsillitis--           Draft    7/22/1998
 Developing Antimicrobial Drugs for Treatment (PDF -
 29 KB)
Uncomplicated and Complicated Skin and Skin           Draft    7/22/1998
 Structure Infections--Developing Antimicrobial
 Drugs for Treatment (PDF - 49 KB)
Uncomplicated Gonorrhea--Developing Antimicrobial     Draft    7/22/
 Drugs for Treatment (PDF - 30 KB)                              1998,
Uncomplicated Urinary Tract Infections--Developing    Draft    7/22/1998
 Antimicrobial Drugs for Treatment (PDF - 42 KB)
Vaccinia Virus--Developing Drugs to Mitigate          Draft    3/8/2004
 Complications from Smallpox Vaccination (PDF - 139
 KB)
Vulvovaginal Candidiasis--Developing Antimicrobial    Draft    7/22/1998
 Drugs for Treatment (PDF - 42 KB)
Clinical / Medical
Acceptance of Foreign Clinical Studies (PDF - 12 KB)  Final    3/12/2001
Acne Vulgaris: Developing Drugs for Treatment (PDF -  Draft    9/16/2005
 284 KB)
Adaptive Design Clinical Trials for Drugs and         Draft    2/25/2010
 Biologics (PDF - 424 KB)
Allergic Rhinitis: Clinical Development Programs for  Draft    6/2000
 Drug Products (PDF - 68 KB)
Antianxiety Drugs--Clinical Evaluation (PDF - 2 MB)   Final    9/1977
Antidepressant Drugs--Clinical Evaluation (PDF - 2    Final    9/1977
 MB)
Assessment of Abuse Potential of Drugs (PDF - 138     Draft    1/26/2010
 KB)
Available Therapy (PDF - 176 KB)                      Final    7/22/2004
Calcium DTPA and Zinc DTPA Drug Products -            Final    8/13/2004
 Submitting a New Drug Application (PDF - 157 KB)
Cancer Drug and Biological Products - Clinical Data   Final    10/11/
 in Marketing Applications (PDF - 39 KB)                        2001
Chronic Cutaneous Ulcer and Burn Wounds--Developing   Final    6/1/2006
 Products for Treatment(PDF - 205 KB)
Chronic Obstructive Pulmonary Disease: Developing     Draft    11/8/2007
 Drugs for Treatment (PDF - 153 KB)
Clinical Development Programs for Drugs, Devices,     Draft    7/07/1999
 and Biological Products Intended for the Treatment
 of Osteoarthritis (PDF - 40 KB)
Clinical Development Programs for Drugs, Devices,     Final    1/1999
 and Biological Products for the Treatment of
 Rheumatoid Arthritis (RA) (PDF - 369 KB)
Clinical Evaluation of Analgesic Drugs (Withdrawn     Final    Withdrawn
 per August 5, 2003, Federal Register Notice)                  8/5/2003
Clinical Evaluation of Antacid Drugs (Withdrawn per   Final    Withdrawn
 July 20, 2004, Federal Register notice.)                      7/20/2004
Clinical Evaluation of Anti-Inflammatory and          Final    Withdrawn
 Antirheumatic Drugs (adults and children)                     5/29/2008
Clinical Evaluation of Antidiarrheal Drugs            Final    Withdrawn
 (Withdrawn per July 20, 2004, Federal Register       Withdra  7/20/2004
 notice.)                                              wn
Clinical Evaluation of Antiepileptic Drugs (adults    Final    1/1981
 and children) (PDF - 1,007 KB)
Clinical Evaluation of Gastric Secretory Depressant   Final    Withdrawn
 (GSD) Drugs (Withdrawn per July 20, 2004, Federal    Withdra  7/20/2004
 Register notice.)                                     wn
Clinical Evaluation of General Anesthetics (PDF -     Final    5/1982
 890 KB)
Clinical Evaluation of Laxative Drugs (Withdrawn per  Final    Withdrawn
 July 20, 2004, Federal Register notice.)             Withdra  7/20/2004
                                                       wn
Clinical Evaluation of Lipid-Altering Agents (PDF -   Draft    Withdrawn
 36 KB)                                                        4/19/2010
Clinical Evaluation of Radiopharmaceutical Drugs      Final    Withdrawn
 (Withdrawn per July 20, 2004, Federal Register       Withdra  7/20/2004
 notice.)                                              wn
Clinical Trial Endpoints for the Approval of Cancer   Final    5/15/2007
 Drugs and Biologics (PDF - 145 KB)
Collection of Race and Ethnicity Data in Clinical     Final    9/16/2005
 Trials (PDF - 70 KB)
Content and Format of Investigational New Drug        Final    11/1995
 Applications (INDs) for Phase 1 Studies of Drugs,
 Including Well-Characterized, Therapeutic,
 Biotechnology-derived Products (PDF - 42 KB)
    [cir] Questions and Answers: Content and Format   .......  .........
     of INDs for Phase 1 Studies of Drugs, Including
     Well-Characterized, Therapeutic, Biotechnology-
     Derived Products (PDF - 14 KB) (10/2000)
Developing Medical Imaging Drug and Biological        Final    6/17/2004
 Products
   Part 1: Conducting Safety Assessments      .......  .........
   (PDF - 271 KB)
   Part 2: Clinical Indications (PDF - 231    .......  .........
   KB)
   Part 3: Design, Analysis, and              .......  .........
   Interpretation of Clinical Studies(PDF - 307 KB)
Developing Products for Weight Management Revision 1  Draft    2/14/2007
 (PDF - 150 KB)
Development and Use of Risk Minimization Action       Final    3/24/2005
 Plans (PDF - 225 KB)
Development of Parathyroid Hormone for the            Draft    5/2000
 Prevention and Treatment of Osteoporosis (PDF - 20
 KB)
Diabetes Mellitus: Developing Drugs and Therapeutic   Draft    2/29/2008
 Biologics for Treatment and Prevention (PDF - 265
 KB)
Diabetes Mellitus--Evaluating Cardiovascular Risk in  Final    12/17/
 New Antidiabetic Therapies to Treat Type 2 Diabetes            2008
 (PDF - 51 KB)
Drugs, Biologics, and Medical Devices Derived from    Draft    9/6/2002
 Bioengineered Plants for Use in Humans and Animals
 (PDF - 88 KB)
Establishing Pregnancy Exposure Registries (PDF -     Final    8/2002
 268 KB)
Establishment and Operation of Clinical Trial Data    Final    3/27/2006
 Monitoring Committees (PDF - 333 KB)

Estrogen and Estrogen/Progestin Drug Products to      Draft    1/2003
 Treat Vasomotor Symptoms and Vulvar and Vaginal
 Atrophy Symptoms--Recommendations for Clinical
 Evaluation (PDF - 198 KB)
Evaluating the Risks of Drug Exposure in Human        Final    4/27/2005
 Pregnancies (PDF - 3 MB)
Exercise-Induced Bronchospasm (EIB)--Development of   Draft    2/2002
 Drugs to Prevent EIB (PDF - 27 KB)
Exocrine Pancreatic Insufficiency Drug Products--     Final    4/13/2006
 Submitting New Drug Applications(PDF - 149 KB)
Female Sexual Dysfunction: Clinical Development of    Draft    5/2000
 Drug Products for Treatment (PDF - 23 KB)
FDA Approval of New Cancer Treatment Uses for         Final    12/1998
 Marketed Drug and Biological Products (PDF - 58 KB)
FDA Requirements for Approval of Drugs to Treat Non-  Final    Posted 3/
 Small Cell Lung Cancer (PDF - 2 MB)                            2/1998
FDA Requirements for Approval of Drugs to Treat       Final    Withdrawn
 Superficial Bladder Cancer (Withdrawn per July 20,   Withdra  7/20/2004
 2004, Federal Register notice.)                       wn
Format and Content of the Clinical and Statistical    Final    7/1988
 Sections of an Application (PDF - 1 MB)
Formatting, Assembling and Submitting New Drug and    Final    2/1987
 Antibiotic Applications* (PDF - 2 MB)
General Considerations for the Clinical Evaluation    Final    .........
 of Drugs (PDF - 1 MB)
General Considerations for the Clinical Evaluation    Final    9/77
 of Drugs in Infants and Children (PDF 2 MB)
Gingivitis: Development and Evaluation of Drugs for   Draft    6/24/
 Treatment or Prevention (PDF -91KB)                            2005
Good Pharmacovigilance Practices and                  Final    3/24/2005
 Pharmacoepidemiologic Assessment (PDF - 220 KB)
Guidance for Clinical Trial Sponsors On the           Final    3/27/2006
 Establishment and Operation of Clinical Trial Data
 Monitoring Committees (PDF - 333KB)
Guidance for Institutional Review Boards, Clinical    Draft    8/29/2006
 Investigators, and Sponsors: Exception from
 Informed Consent Requirements for Emergency
 Research (PDF - 2 MB)
Guidance for the Development of Vaginal               Final    3/2/1998
 Contraceptive Drugs (NDA)(PDF - 465 KB)
Hypnotic Drugs--Clinical Evaluation (PDF - 2MB)       Final    9/77
IND Exemptions for Studies of Lawfully Marketed Drug  Final    Revised
 or Biological Products for the Treatment of Cancer            1/15/2004
 (PDF - 188 KB)
Inhalation Drug Products Packaged in Semipermeable    Draft    7/2002
 Container Closure Systems (PDF - 27 KB)
Integration of Dose-Counting Mechanisms into MDI      Final    3/2003
 Drug Products (PDF - 126 KB)
Internal Radioactive Contamination--Development of    Final    3/1/2006
 Decorporation Agents (PDF - 177 KB)
Irritable Bowel Syndrome--Clinical Evaluation of      Draft    3/22/2010
 Products for Treatment (PDF 221 KB)
Levothyroxine Sodium Tablets - In Vivo                Final    2/2001
 Pharmacokinetic and Bioavailability Studies and In
 Vitro Dissolution Testing (PDF - 27 KB)
Local Anesthetics--Clinical Evaluation (PDF - 1 MB    Final    3/2/1998
Malaria: Developing Drug and Nonvaccine Biological    Draft    6/6/2007
 Products for Treatment and Prophylaxis (PDF - 344
 KB)
MDI and DPI Drug Products--Clinical Development       Final    9/19/1994
 Programs for (PDF - 699 KB)
Non-Inferiority Clinical Trials (PDF - 565 KB)        Draft    2/26/2010
Pediatric Use Supplements--Content and Format (PDF -  Final    5/1996
 24 KB)
Oncologic Drugs Advisory Committee Discussion on FDA  Final    Posted
 Requirements or Approval of New Drugs for Treatment           3/2/1998
 of Colon and Rectal Cancer (PDF - 2 MB)
Orally Inhaled and Intranasal Corticosteroids:        Final    3/5/2007
 Evaluation of the Effects on Growth in Children
 (PDF - 247 KB)
OTC Treatment of Herpes Labialis with Antiviral       Draft    Withdrawn
 Agents (PDF - 15 KB)                                          3/18/2010
Patient-Reported Outcome Measures: Use in Medical     Final    12/8/2009
 Product Development to Support Labeling Claims (PDF
 -295 KB)
Pediatric Oncology Studies In Response to a Written   Draft    6/2000
 Request (PDF - 30 KB)
Postmarketing Adverse Experience Reporting for Human  Final    8/27/1997
 Drug and Licensed Biological Products:
 Clarification of What to Report (PDF - 95 KB)
Postmarketing Reporting of Adverse Drug Experiences   Final    3/1992
 (PDF - 7 MB)
Preclinical and Clinical Evaluation of Agents Used    Draft    Withdrawn
 in the Prevention or Treatment of Postmenopausal     Withdra  12/2009
 Osteoporosis (PDF - 50 KB) Withdrawn                  wn
Premarketing Risk Assessment(PDF - 88 KB)             Final    3/24/2005
Providing Clinical Evidence of Effectiveness for      Final    5/14/1998
 Human Drug and Biological Products (PDF - 129 KB)
Prussian Blue Drug Products--Submitting a New Drug    Final    1/2003
 Application (PDF - 178 KB)
Psychoactive Drugs in Infants and Children--Clinical  Final    3/2/1998
 Evaluation (PDF - 18 MB)
The Radioactive Drug Research Committee: Human        Draft    6/2/2009
 Research Without An Investigational New Drug
 Application (PDF - 421 KB)
Recommendations for Complying with the Pediatric      Draft    Posted
 Rule (21 CFR 314.55(a) and 601.27(a)) (PDF - 56 KB)           12/1/2000
Sinusitis: Designing Clinical Development Programs    Draft    Posted
 of Nonantimicrobial Drugs for Treatment (PDF - 113            11/21/
 KB)                                                            2006
Study and Evaluation of Gender Differences in the     Final    7/22/1993
 Clinical Evaluation of Drugs (PDF - 2 MB)
Study of Drugs Likely to be used in the Elderly (PDF  Final    11/1989
 - 1MB)
Submission of Abbreviated Reports and Synopses in     Final    8/1999
 Support of Marketing Applications (PDF - 43 KB)
Summary for New Drug and Antibiotic Applications--    Final    2/1987
 Format and Content of the Summary for New Drug and
 Antibiotic Applications (PDF - 1 MB)
Systemic Lupus Erythematosus--Developing Drugs for    Draft    3/28/2005
 Treatment (PDF - 403 KB)
The Use of Clinical Holds Following Clinical          Final    9/2004
 Investigator Misconduct (PDF - 33 KB)
Waiver of IRB Requirements for Drug and Biological    Final    1/2006
 Product Studies (PDF - 33 KB)
Clinical Pharmacology
Clinical Lactation Studies--Study Design, Data        Draft    Issued
 Analysis, and Recommendations for Labeling (PDF -             2/7/05
 363 KB)
Drug Interaction Studies--Study Design, Data          Draft    Issued
 Analysis, and Implications for Dosing and Labeling            9/11/2006
 (PDF - 253 KB)

Drug Metabolism/Drug Interaction Studies in the Drug  Final    4/1997
 Development Process: Studies In Vitro (PDF - 109
 KB)
Exposure-Response Relationships--Study Design, Data   Final    5/5/2003
 Analysis, and Regulatory Applications (PDF - 221
 KB)
Format and Content of the Human Pharmacokinetics and  Final    2/1987
 Bioavailability Section of an Application (PDF -
 519 KB)
General Considerations for Pediatric Pharmacokinetic  Draft    11/1998
 Studies for Drugs and Biological Products (PDF - 37
 KB)
In Vivo Drug Metabolism/Drug Interaction Studies -    Final    11/24/
 Study Design, Data Analysis, and Recommendations               1999
 for Dosing and Labeling (PDF - 44 KB)
Pharmacokinetics in Patients with Impaired Renal      Draft    3/17/2010
 Function--Study Design, Data Analysis, and Impact
 on Dosing and Labeling (PDF - 151 KB)
Pharmacokinetics in Patients with Impaired Hepatic    Final    Posted
 Function: Study Design, Data Analysis, and Impact             5/30/2003
 on Dosing and Labeling (PDF - 222 KB)
Pharmacokinetics in Patients with Impaired Renal      Final    5/14/1998
 Function (PDF - 128 KB)
Pharmacokinetics in Pregnancy--Study Design, Data     Draft    10/29/
 Analysis, and Impact on Dosing and Labeling (PDF -             2004
 324 KB)
Population Pharmacokinetics (PDF - 135 KB)            Final    2/1999
Combination Products
Coronary Drug-Eluting Stents-Nonclinical and          .......  .........
 Clinical Studies (PDF - 120 KB)
   Coronary Drug-Eluting Stents--Nonclinical  .......  .........
   and Clinical Studies -Companion Document (PDF -
   295 KB)
Current Good Manufacturing Practices (CGMPs)/Compliance
Bar Code Label Requirements--Questions and Answers    Final    10/5/2006
 (PDF - 101 KB)
Comparability Protocols - Protein Drug Products and   Draft    9/3/2003
 Biological Products - Chemistry, Manufacturing, and
 Controls Information (PDF - 82 KB)
Compressed Medical Gases                              Final    2/1989
Computerized Systems Used in Clinical Investigations  Final    5/10/2007
 (PDF - 53 KB)
Current Good Manufacturing Practice for Combination   Draft    9/29/2004
 Products (PDF - 350 KB)
Current Good Manufacturing Practice for Medical       Draft    5/6/2003
 Gases (PDF - 437 KB)
Current Good Manufacturing Practice for Phase 1       Final    7/14/2008
 Investigational Drugs (PDF - 132 KB)
Dosage Delivery Devices for OTC Liquid Drug Products  Draft    11/04/
 (PDF -93 KB)                                                   2009
Expiration Dating and Stability Testing of Solid      Final    6/27/1997
 Oral Dosage Form Drugs Containing Iron (PDF - 88
 KB)
Expiration Dating of Unit-Dose Repackaged Drugs:      Draft    5/27/2005
 Compliance Policy Guide (PDF - 19 KB)
Formal Dispute Resolution: Scientific and Technical   Final    1/11/2006
 Issues Related to Pharmaceutical CGMP (PDF - 110
 KB)
General Principles of Process Validation              Final    5/1987
Good Laboratory Practice Regulations Questions and    Final    3/2/1998
 Answers (PDF - 2 MB)
Guidance for Hospitals, Nursing Homes, and Other      Final    4/5/2001
 Health Care Facilities - FDA Public Health Advisory
 (PDF - 19 KB)
Guidance for IRBs, Clinical Investigators, and        Draft    8/29/2006
 Sponsors: Exception from Informed Consent
 Requirements for Emergency Research (21 CFR 50.24)
 (PDF - 3 MB)
 Draft released for comment
Guideline for Validation of Limulus Amebocyte Lysate  Final    Posted
 Test as an End-Product Endotoxin Test for Human and           3/2/1998
 Animal Parenteral Drugs, Biological Products, and
 Medical Devices (PDF - 4 MB)
Investigating Out-of-Specification Test Results for   Final    10/11/
 Pharmaceutical Production (PDF - 98 KB)                        2006
Manufacturing, Processing, or Holding Active          Draft    4/17/1998
 Pharmaceutical Ingredients (PDF - 150 KB)
Marketed Unapproved Drugs--Compliance Policy Guide    Final    6/8/2006
 (PDF - 66 KB)
Monitoring of Clinical Investigations (PDF - 433 KB)  Final    Posted
                                                               3/2/1998
Nuclear Pharmacy Guideline Criteria for Determining   Final    Posted
 When to Register as a Drug Establishment (PDF - 3             3/2/1998
 MB)
Part 11, Electronic Records; Electronic Signatures--  Final    9/3/2003
 Scope and Application (PDF - 215 KB)
PAT--A Framework for Innovative Pharmaceutical        Final    9/29/2004
 Development, Manufacturing, and Quality Assurance
 (PDF - 315 KB)
PET Drug Products - Current Good Manufacturing        Final    9/15/2005
 Practice (CGMP) (PDF - 399 KB)
Pharmaceutical Components at Risk for Melamine        Final    8/6/2009
 Contamination (PDF - 137 KB)
Pharmacy Compounding--Compliance Policy Guide (PDF -  Final    5/2002
 793 KB)
Possible Dioxin/PCB Contamination of Drug and         Final    8/23/1999
 Biological Products (PDF - 8 KB)
Powder Blends and Finished Dosage Units--Stratified   Draft    11/2003
 In-Process Dosage Unit Sampling and Assessment (PDF
 - 297 KB)
   Revised Attachments (PDF - 159 KB)         .......  .........
Preparation of Investigational New Drug Products      Final    11/1992
 (Human and Animal)(PDF - 795 KB)
Prescription Drug Marketing Act--Donation of          Final    3/2006
 Prescription Drug Samples to Free Clinics (PDF - 38
 KB)
   Prescription Drug Marketing Act (PDMA)     .......  .........
   Requirements- Questions and Answers (PDF - 112
   KB) (Issued and Posted 11/13/2006)
Process Validation: General Principles and Practices  Draft    11/17/
 (PDF - 194 KB)                                                 2008
Quality Systems Approach to Pharmaceutical Current    Final    9/27/2006
 Good Manufacturing Practice Regulations (PDF - 443
 KB)
Questions and Answers on Current Good Manufacturing   Final    8/4/2004
 Practices (cGMP) for Drugs(updated 6/29/2009
Review of FDA's Implementation of the Drug Export     Final    11/1989
 Amendments of 1986 (PDF - 2 MB)
Sterile Drug Products Produced by Aseptic             Final    9/29/2004
 Processing--Current Good Manufacturing Practice
 (PDF - 734 KB)
Street Drug Alternatives (PDF - 11 KB)                Final    3/2000
Testing of Glycerin for Diethylene Glycol (PDF - 36   Final    5/1/2007
 KB)

The Use of Mechanical Calibration of Dissolution      Final    1/26/2010
 Apparatus 1 and 2--Current Good Manufacturing
 Practice (CGMP)(PDF - 38 KB)
Drug Safety
Conducting a Clinical Safety Review of a New Product  Final    2/2005
 Application and Preparing a Report on the Review
 (PDF - 1516 KB)
Drug-Induced Liver Injury: Premarketing Clinical      Final    7/29/2009
 Evaluation (PDF - 206 KB)
Drug Safety Information - FDA's Communication to the  Final    3/2/2007
 Public (PDF - 114 KB)
Format and Content of Proposed Risk Evaluation and    Draft    9/30/2009
 Mitigation Strategies (REMS), REMS Assessments, and
 Proposed REMS Modifications (PDF - 316 KB)
Postmarketing Studies and Clinical Trials--           Draft    7/15/2009
 Implementation of Section 505(o) of the Federal
 Food, Drug, and Cosmetic Act (PDF - 173 KB)
Electronic Submissions
Indexing Structured Product Labeling (PDF - 59 KB)    Final    6/2/2008
Part 11, Electronic Records; Electronic Signatures--  Final    9/3/2003
 Scope and Application (PDF - 215 KB)
Providing Regulatory Submissions in Electronic        Final    6/2002
 Format--ANDAs                                        Withdra
Withdrawn FR Notice 10/5/2006                          wn
                                                      FR
                                                       Notice
Providing Regulatory Submissions in Electronic        Draft    Posted
 Format -Annual Reports for NDAs and ANDAs            Withdra  8/27/2003
Withdrawn FR Notice 10/5/2006                          wn
                                                      FR
                                                       Notice
Providing Regulatory Submissions in Electronic        Final    4/20/2005
 Format--Content of Labeling (PDF - 28 KB)
Providing Regulatory Submissions in Electronic        Final    5/28/2009
 Format--Drug Establishment Registration and Drug
 Listing (PDF - 123 KB)
Providing Regulatory Submissions in Electronic        Final    Revised
 Format -Human Pharmaceutical Product Applications             06/11/
 and Related Submissions Using the eCTD                         2008
 Specifications(PDF - 133 KB)
 To ensure that you have the most recent versions of
 the specifications referenced in this document,
 check the appropriate center's Web page. CBER
 Topics page. CDER Topics page.
Providing Regulatory Submissions in Electronic        Draft    10/2003
 Format -General Considerations (PDF - 288 KB)
 (Issued, Posted 10/22/2003)
Providing Regulatory Submissions in Electronic        Draft    6/11/2008
 Format-Postmarketing Individual Case Safety Reports
 (PDF - 107 KB)
 To ensure that you have the most recent versions of
 the specifications referenced in this document,
 check the appropriate center's Web page. CBER
 Topics page. CDER Topics page.
Providing Regulatory Submissions in Electronic        Draft    1/2001
 Format - Prescription Drug Advertising and
 Promotional Labeling (PDF - 28 KB)
Providing Regulatory Submissions in Electronic        Draft    6/4/2007
 Format--Receipt Date (PDF - 59 KB)
Regulatory Submissions in Electronic Format; General  Final    1/1999
 Considerations (PDF - 54 KB)
Regulatory Submissions in Electronic Format; New      Final    1/1999
 Drug Applications                                    Withdra
Withdrawn FR Notice 10/5/2006                          wn
                                                      FR
                                                       Notice
SPL Standard for Content of Labeling Technical Qs &   Draft    10/2009
 As (PDF - 58 KB)
FDAAA (Food and Drug Administration Amendments Act)
Certifications To Accompany Drug, Biological          Draft    4/2008
 Product, and Device Applications/Submissions:
 Compliance with Section 4020) of The Public Health
 Service Act, Added By Title VIII of The Food and
 Drug Administration Amendments Act of 2007 (PDF -
 314 KB)
Generics
180-Day Exclusivity When Multiple ANDAs Are           Final    7/2003
 Submitted on the Same Day (PDF - 162 KB)
Alternate Source of the Active Pharmaceutical         Final    12/2000
 Ingredient in Pending ANDAs (PDF - 14 KB)
ANDAs: Impurities in Drug Products (PDF - 104 KB)     Draft    8/26/2005
ANDAs: Impurities in Drug Substances (PDF - 136 KB)   Final    7/15/2009
ANDAs:Pharmaceutical Solid Polymorphism: Chemistry,   Final    7/6/2007
 Manufacturing, and Controls Information (PDF - 125
 KB)
Court Decisions, ANDA Approvals, and 180-Day          Final    3/2000
 Exclusivity Under the Hatch-Waxman Amendments to
 the Federal Food, Drug, and Cosmetic Act (PDF - 25
 KB)
Handling and Retention of Bioavailability and         Final    5/25/2004
 Bioequivalence Testing Samples (PDF - 166 KB)
Individual Product Bioequivalence Recommendations     Draft    5/30/2007
 (PDF - 45 KB)
List of Product Bioequivalence Recommendations
Letter announcing that the OGD will now accept the    Final    8/1995
 ICH long-term storage conditions as well as the
 stability studies conducted in the past. (PDF - 194
 KB)
Letter describing efforts by the CDER and the ORA to  Final    10/1994
 clarify the responsibilities of CDER chemistry
 review scientists and ORA field investigators in
 the new and abbreviated drug approval process in
 order to reduce duplication or redundancy in the
 process (PDF - 274 KB)
Letter on incomplete Abbreviated Applications,        Final    4/1994
 Convictions Under GDEA, Multiple Supplements,
 Annual Reports for Bulk Antibiotics, Batch Size for
 Transdermal Drugs, Bioequivalence Protocols,
 Research, Deviations from OGD Policy (PDF - 1915
 KB)
Letter on the Provision of new information            Final    7/1992
 pertaining to new bioequivalence guidelines and
 refuse-to-file letters (PDF - 254 KB)
Letter on the provision of new procedures and         Final    3/1989
 policies affecting the generic drug review process
 (PDF - 608 KB)
Letter on the request for cooperation of regulated    Final    11/1990
 industry to improve the efficiency and
 effectiveness of the generic drug review process,
 by assuring the completeness and accuracy of
 required information and data submissions (PDF -
 917 KB)
Letter on the response to 12/20/1984 letter from the  Final    3/1985
 Pharmaceutical Manufacturers Association about the
 Drug Price Competition and Patent Term Restoration
 Act(PDF - 392 KB)

Letter to all ANDA and AADA applicants about the      Final    1/1993
 Generic Drug Enforcement Act of 1992 (GDEA), and
 the Office of Generic Drugs intention to refuse-to-
 file incomplete submissions as required by the new
 law (PDF - 233 KB)
Letter to regulated industry notifying interested     Final    8/1993
 parties about important detailed information
 regarding labeling, scale-up, packaging, minor/
 major amendment criteria and bioequivalence
 requirements (PDF - 908 KB)
Listed Drugs, 30-Month Stays, and Approval of ANDAs   Draft    10/2004
 and 505(b)(2) Applications Under Hatch-Waxman, as
 Amended by the Medicare Prescription Drug,
 Improvement, and Modernization Act of 2003--
 Questions and Answers (PDF - 57 KB)
Major, Minor, and Telephone Amendments to             Final    12/2001
 Abbreviated New Drug Applications (PDF - 24 KB)
Potassium Chloride Modified-Release Tablets and       Final    10/25/
 Capsules: In Vivo Bioequivalence and In Vitro                  2005
 Dissolution Testing (PDF - 48 KB)
Revising ANDA Labeling Following Revision of the RLD  Final    4/26/2000
 Labeling (PDF - 19 KB)
Submission of Summary Bioequivalence Data for         Draft    4/16/2009
 Abbreviated New Drug Applications (PDF - 183 KB)
Variations in Drug Products that May Be Included in   Final    12/1998
 a Single ANDA (PDF - 107 KB)
Good Review Practices
Conducting a Clinical Safety Review of a New Product  Final    2/2005
 Application and Preparing a Report on the Review
 (PDF - 1516 KB)
Guidance for Sponsors, Industry, Researchers,         Final    1/21/2009
 Investigators, and Food and Drug Administration
 Staff : Certifications To Accompany Drug,
 Biological Product, and Device Applications/
 Submissions: Compliance with Section 402(j) of The
 Public Health Service Act, Added By Title VIII of
 The Food and Drug Administration Amendments Act of
 2007
Pharmacology/Toxicology Review Format (PDF - 55 KB)   Final    5/2001
International Conference on Harmonisation - Efficacy
E1A The Extent of Population Exposure to Assess       Final    3/1995
 Clinical Safety: For Drugs Intended for Long-term
 Treatment of Non-Life-Threatening Conditions (PDF -
 17 KB)
E2A Clinical Safety Data Management: Definitions and  Final    3/1995
 Standards for Expedited Reporting (PDF - 49 KB)
E2B International Conference on Harmonisation;        Final    1/15/1998
 Guidance on Data Elements for Transmission of
 Individual Case Safety Reports (PDF - 69 KB)
   E2BM Data Elements for Transmission Of     .......  .........
   Individual Case Safety Reports (PDF - 74 KB)
   (Issued 4/2002, Posted 4/4/2002)
    [cir] E2B(M) Questions and Answers (PDF - 55 KB)  .......  .........
     (Revised 3/09/2005, Posted, 3/16/2005)
E2B(R) Clinical Safety Data Management: Data          Draft    9/30/2005
 Elements for Transmission of Individual Case Safety
 Reports (PDF - 269 KB) (Issued , Posted 9/30/2005)
E2C(R1) Clinical Safety Data Management: Periodic     .......  .........
 Safety Update Reports for Marketed Drugs
 Note: In November 2005, the ICH incorporated the
 E2C addendum with the E2C parent guidance and
 retitled the combined document E2C(R1). The
 contents of the two guidances were not revised.
   E2C Clinical Safety Data Management:       Final    5/19/1997
   Periodic Safety Update Reports for Marketed Drugs
   (PDF - 169 KB)
   E2C Addendum to ICH E2C Clinical Safety    Final    2/5/2004
   Data Management: Periodic Safety Update Reports
   for Marketed Drugs (PDF - 35 KB)
E2D Postapproval Safety Data Management: Definitions  Draft    9/12/2003
 and Standards for Expedited Reporting (PDF - 184
 KB)
E2E Pharmacovigilance Planning (PDF - 73 KB)          Final    3/31/05
E2F Development Safety Update Report (PDF - 118 KB)   Draft    8/4/2008
E3 Structure and Content of Clinical Study Reports    Final    7/1996
 (PDF - 240 KB)
E4 Dose-Response Information to Support Drug          Final    7/1996
 Registration (PDF - 49 KB)
E5 Ethnic Factors in the Acceptability of Foreign     .......  .........
 Clinical Data
   E5 Questions and Answers (PDF - 48 KB)     Final    6/2004
   [Issued 9/27/2006; Posted 9/28/2006]
E6 Good Clinical Practice: Consolidated Guideline     Final    5/9/1997
 (PDF - 262 KB)
Spanish Version (PDF - 151 kb)
E7 Studies in Support of Special Populations:         Final    8/1994
 Geriatrics (PDF - 25 KB)
E7 Studies in Support of Special Populations;         Draft    11/9/2009
 Geriatrics; Questions and Answers (PDF - 125 KB)
E8 General Considerations for Clinical Trials (PDF -  Final    12/1997
 67 KB)
E9 Statistical Principles for Clinical Trials (PDF -  Final    9/1/1998
 110 KB)
E10 Choice of Control Group and Related Issues in     Final    5/2001
 Clinical Trials (PDF - 93 KB)
E11 Clinical Investigation of Medicinal Products in   Final    12/2000
 the Pediatric Population (PDF - 60 KB)
E12A Principles for Clinical Evaluation of New        Draft    8/2000
 Antihypertensive Drugs. (PDF - 27 KB)
E14 Clinical Evaluation of QT/QTc Interval            Final    10/19/
 Prolongation and Proarrhythmic Potential for Non-              2005
 Antiarrhythmic Drugs (PDF - 67 KB)
Questions and Answers (PDF - 108 KB)                  .......  11/18/
                                                                2008
E15 Pharmacogenomics Definitions and Sample Coding    Final    4/7/2008
 (PDF - 90 KB)
E16 Genomic Biomarkers Related to Drug Response:      Draft    7/30/2009
 Context, Structure, and Format of Qualification
 Submissions (PDF - 135 KB)
International Conference on Harmonisation - Joint Safety/Efficacy
 (Multidisciplinary)
M2 eCTD: Electronic Common Technical Document         Final    4/1/2003
 Specification (PDF - 1,020 KB)
   M2: eCTD Specification Questions and       .......  3/14/05
   Answers and Change Requests (PDF 17 KB)
   Companion Document: Current Q & As and     .......  7/10/2008
   Change Requests
M3(R2) Nonclinical Safety Studies for the Conduct of  Final    1/20/2010
 Human Clinical Trials and Marketing Authorization
 for Pharmaceuticals (PDF - 295 KB)
M4: Common Technical Document for the Registration    Final    Originall
 of Pharmaceuticals for Human Use                               y
                                                               Issued
                                                               10/15/
                                                                2001
   M4: Organization of the CTD (PDF - 31 KB)  .......  .........

   M4 Granularity Annex (PDF - 124 KB)        .......  .........
   (Issued 10/18/2005, Posted 10/18/2005)
   M4: The CTD--General Questions and         .......  .........
   Answers (PDF - 29 KB) (Issued 12/04, Posted 12/22/
   2004)
   M4: The CTD--Quality (PDF - 79 KB)         .......  .........
   M4: The CTD--Quality Questions and         .......  .........
   Answers /Location Issues (PDF - 49 KB) (Issued 6/
   2004, Posted 6/8/2004)
   M4: The CTD--Efficacy (PDF - 156 KB)       .......  .........
   M4: The CTD--Efficacy Questions and        .......  .........
   Answers (PDF - 34 KB) (Issued 12/2004, Posted 12/
   22/2004)
   Clarification for Q&A 10 on submitting integrated
   summaries of safety and effectiveness (ISS/ISE)
   in the eCTD format [esrs/eCTD page].
   M4: The CTD--Safety (PDF - 60 KB)          .......  .........
   M4: The CTD--Safety Appendices (PDF - 178  .......  .........
   KB)
    [cir] M4: The CTD--Safety Questions and Answers   .......  .........
     (PDF - 16 KB) (Issued 2/2003, Posted 2/4/2003)
M5 International Conference on Harmonisation; Draft   Draft    9/2005
 Guidance on M5 Data Elements and Standards for Drug
 Dictionaries (PDF - 288 KB)
Submitting Marketing Applications According to the    Draft    9/2001
 ICH/CTD Format: General Considerations (PDF - 50
 KB)
International Conference on Harmonisation - Quality
Q1A(R2) Stability Testing of New Drug Substances and  Final    11/2003
 Products (PDF - 58 KB)
Q1B Photostability Testing of New Drug Substances     Final    11/1996
 and Products (PDF - 339 KB)
Q1C Stability Testing for New Dosage Forms (PDF -     Final    5/9/1997
 101 KB)
Q1D Bracketing and Matrixing Designs for Stability    Final    1/2003
 Testing of New Drug Substances and Products (PDF -
 31 KB)
Q1E Evaluation of Stability Data (PDF - 221 KB)       Final    6/2004
Q1F Stability Data Package for Registration           Final    Withdrawn
 Applications in Climatic Zones III and IV, revision           7/6/2006
 1
Q2(R1) Validation of Analytical Procedures: Text and  .......  .........
 Methodology
 Note: In November 2005, the ICH incorporated Q2B on
 methodology with the parent guidance Q2A and
 retitled the combined Q2 document. The contents of
 the two guidances were not revised.
   Q2A Text on Validation of Analytical       Final    3/1995
   Procedures (PDF - 25 KB)
   Q2B Validation of Analytical Procedures:   Final    5/19/1997
   Methodology (PDF - 132 KB)
Q3A(R) Impurities in New Drug Substances (PDF - 55    Final    6/6/2008
 KB)
Q3B(R) Impurities in New Drug Products (Revision      Final    8/4/2006
 2)(PDF - 171 KB)
Q3C Impurities: Residual Solvents (PDF - 41 KB)       Final    12/24/
                                                                1997
Q3C Tables and List (PDF - 33 KB)                     Final    11/12/
                                                                2003
   Appendix 4 (PDF - 120 KB); Appendix 5      Final    2/11/2002
   (PDF - 216 KB); Appendix 6 (PDF - 128 KB)
   (Appendices were issued with the Q3C draft
   guidance documents)
   Maintenance Procedures for Updating
Q4B Evaluation and Recommendation of Pharmacopoeial   Final    2/20/2007
 Texts for Use in the International Conference on
 Harmonisation Regions (PDF - 55 KB)
   Annex I: Residue on Ignition/Sulphated     Final    2/20/2007
   Ash General Chapter (PDF - 36 KB)
   Annex 2: Test for Extractable Volume of    Final    1/8/2009
   Parenteral Preparations General Chapter (PDF - 79
   KB)
   Annex 3: Test for Particulate              Final    1/8/2009
   Contamination: Subvisible Particles General
   Chapter (PDF - 1208 KB)
   Annex 4A: Microbiological Examination of   Final    4/7/2009
   Non-Sterile Products: Microbial Enumeration Tests
   General Chapter (PDF - 81 KB)
   Annex 4B: Microbiological Examination of   .......  .........
   Non-Sterile Products: Tests for Specified Micro-
   organisms General Chapter (PDF - 82 KB)
   Annex 4C: Microbiological Examination of   .......  .........
   Non-Sterile Products: Acceptance Criteria for
   Pharmaceutical Preparations and Substances for
   Pharmaceutical Use General Chapter (PDF - 75 KB)
   Annex 5: Disintegration Test General       Final    12/22/
   Chapter (PDF - 32 KB)                                        2009
   Annex 6:Uniformity of Dosage Units         Final    4/2/2010
   General Chapter (PDF - 87 KB)
   Annex 7:Dissolution Test General Chapter
   (PDF - 93 KB)
   Annex 8: Sterility Test General Chapter    Final    12/22/
   (PDF - 32 KB)                                                2009
   Annex 9: Tablet Friability General         Final    4/2/2010
   Chapter (PDF - 84 KB)
   Annex 10: Polyacrylamide Gel               Final    4/9/2010
   Electrophoresis General Chapter (PDF - 84 KB)
   Annex 11: Capillary Electrophoresis        .......  .........
   General Chapter (PDF - 90 KB)
   Annex 12: Analytical Sieving General       Draft    12/16/
   Chapter (PDF - 313 KB)                                       2009
Q5A Viral Safety Evaluation of Biotechnology          Final    Posted
 Products Derived From Cell Lines of Human or Animal           9/1998
 Origin (PDF - 71 KB)
Q5B Quality of Biotechnological Products: Analysis    Final    2/1996
 of the Expression Construct in Cells Used for
 Production of r-DNA Derived Protein Products (PDF -
 109 KB)
Q5C Quality of Biotechnological Products: Stability   Final    7/1996
 Testing of Biotechnological/Biological Products
 (PDF - 70 KB)
Q5D Quality of Biotechnological/Biological Products:  Final    9/21/1998
 Derivation and Characterization of Cell Substrates
 Used for Production of Biotechnological/Biological
 Products; Availability (PDF - 52 KB)34 (Issued ,
 Posted 9/21/1998)
Q5E Comparability of Biotechnological/Biological      Final    6/2005
 Products Subject to Changes in Their Manufacturing
 Process (PDF - 58 KB)
Q6A International Conference on Harmonisation;        Final    12/29/
 Guidance on Q6A Specifications: Test Procedures and            2000
 Acceptance Criteria for New Drug Substances and New
 Drug Products: Chemical Substances.
Q6B Specifications: Test Procedures and Acceptance    Final    8/1999
 Criteria for Biotechnological/Biological Products
 (PDF - 64 KB)
Q7A Good Manufacturing Practice Guidance for Active   Final    8/2001
 Pharmaceutical Ingredients (PDF - 175 KB)
Note: In November 2005, the ICH redesignated this
 guidance. Q7 The guidance was not revised.
Q8(R2) Pharmaceutical Development (PDF - 402 KB)      Final    11/20/
                                                                2009

Q9 Quality Risk Management (PDF - 113 KB)             Final    6/1/2006
Q10 Pharmaceutical Quality System (PDF - 274 KB)      Final    4/7/2009
International Conference on Harmonisation - Safety
S1A The Need for Long-term Rodent Carcinogenicity     Final    3/1996
 Studies of Pharmaceuticals (PDF - 100 KB)
S1B Testing for Carcinogenicity of Pharmaceuticals    Final    2/28/1998
 (PDF - 145 KB)
S1C(R2) Dose Selection for Carcinogenicity Studies    Final    9/17/2008
 of Pharmaceuticals (PDF - 185 KB)
S2A Specific Aspects of Regulatory Genotoxicity       Final    4/1996
 Tests for Pharmaceuticals (PDF - 123 KB)
S2B Genotoxicity: A Standard Battery for              Final    11/21/
 Genotoxicity Testing of Pharmaceuticals (PDF - 131             1997
 KB)
S2(R1) Genotoxicity Testing and Data Interpretation   Draft    3/24/2008
 for Pharmaceuticals Intended for Human Use(PDF -
 242 KB)
S3A Toxicokinetics: The Assessment of Systemic        Final    3/1995
 Exposure in Toxicity Studies (PDF - 46 KB)
S3B Pharmacokinetics: Guidance for Repeated Dose      Final    3/1995
 Tissue Distribution Studies (PDF - 14 KB)
S4A Duration of Chronic Toxicity Testing in Animals   Final    Posted
 (Rodent and Nonrodent Toxicity Testing)(PDF - 21              6/25/99
 KB)
S5(R2) Detection of Toxicity to Reproduction for      .......  .........
 Medicinal Products Toxicity to Male Fertility
 Note: In November 2005, the ICH incorporated the
 S5B addendum with S5A and retitled the combined S5
 document. The contents of the two guidances were
 not revised.
   S5A Detection of Toxicity to Reproduction  Final    9/1994
   for Medicinal Products (PDF - 87 KB)
   S5B Detection of Toxicity to Reproduction  Final    4/1996
   for Medicinal Products: Addendum on Toxicity to
   Male Fertility (PDF - 98 KB)
S6 Preclinical Safety Evaluation of Biotechnology-    Final    11/1997
 Derived Pharmaceuticals (PDF - 137 KB)
   Addendum to ICH S6:(PDF - 160 KB)          Draft    12/16/
   Preclinical Safety Evaluation of Biotechnology -             2009
   Derived Pharmaceuticals S6(R1)
S7A Safety Pharmacology Studies for Human             Final    7/2001
 Pharmaceuticals (PDF - 44 KB)
S7B Nonclinical Evaluation of the Potential for       Final    10/19/
 Delayed Ventricular Repolarization (QT Interval                2005
 Prolongation) by Human Pharmaceuticals (PDF - 52
 KB)
S8 Immunotoxicity Studies for Human Pharmaceuticals   Final    4/12/2006
 (PDF - 72 KB)
S9 Nonclinical Evaluation for Anticancer              Final    3/5/2010
 Pharmaceuticals (PDF - 170 KB)
Investigational New Drug Applications
Content and Format of Investigational New Drug        Final    11/1995
 Applications (INDs) for Phase 1 Studies of Drugs,
 Including Well-Characterized, Therapeutic,
 Biotechnology-derived Products (PDF - 42 KB)
   Questions and Answers: Content and Format  .......  .........
   of INDs for Phase 1 Studies of Drugs, Including
   Well-Characterized, Therapeutic, Biotechnology-
   Derived Products (PDF - 14 KB) (10/2000)
Exploratory IND Studies (PDF - 220 KB)                Final    1/12/2006
Labeling
Adverse Reactions Section of Labeling for Human       Final    1/18/2006
 Prescription Drug and Biological Products--Content
 and Format (PDF - 52 KB)
Clinical Pharmacology Section of Labeling for Human   Draft    3/3/2009
 Prescription Drug and Biological Products--Content
 and Format (PDF - 144 KB)
Clinical Studies Section of Labeling for Human        Final    1/18/2006
 Prescription Drug and Biological Products--Content
 and Format(PDF - 127 KB)
Content and Format for Geriatric Labeling (PDF - 38   Final    10/2001
 KB)
Contents of a Complete Submission for the Evaluation  Final    2/5/2010
 of Proprietary Names (PDF - 306 KB)
Dosage and Administration Section of Labeling for     Final    3/22/2010
 Human Prescription Drug and Biological Products -
 Content and Format (PDF - 143 KB)
Hypertension Indication: Drug Labeling for            Draft    3/12/2008
 Cardiovascular Outcome Claims (PDF - 53 KB)
Labeling for Combined Oral Contraceptives (PDF - 92   Draft    3/2/2004
 KB)
Labeling for Human Prescription Drugs--Determining    Final    10/16/
 Established Pharmacologic Class for Use in the                 2009
 Highlights of Prescribing Information (PDF - 66 KB)
Labeling for Human Prescription Drug and Biological   Draft    1/18/2006
 Products--Implementing the New Content and Format
 Requirements (PDF - 213 KB)
Labeling Guidance for OTC Topical Drug Products for   Draft    6/1998
 the Treatment of Vaginal Yeast Infections
 (Vulvovaginal Candidiasis) (PDF - 71 KB)
Noncontraceptive Estrogen Drug Products for the       Draft    11/15/
 Treatment of Vasomotor Symptoms and Vulvar and                 2005
 Vaginal Atrophy Symptoms--Recommended Prescribing
 Informtion for Health Care Providers and Patient
 Labeling (PDF - 458 KB)
Public Availability of Labeling Changes in ``Changes  Draft    9/19/2006
 Being Effected'' Supplements (PDF - 26 KB)
Referencing Discontinued Labeling for Listed Drugs    Draft    10/26/
 in Abbreviated New Drug Applications (PDF - 32 KB)             2000
Updating Labeling for Susceptibility Test             Final    6/26/2009
 Information in Systemic Antibacterial Drug Products
 and Antimicrobial Susceptibility Testing Devices
 (PDF - 188 KB)
Warnings and Precautions, Contraindications, and      Draft    1/18/2006
 Boxed Warning Sections of Labeling for Human
 Prescription Drug and Biological Products--Content
 and Format (PDF - 58 KB)
Microbiology
Format and Content of the Microbiology Section of an  Final    1990
 Application* (PDF - 546 KB)
Modernization Act
Changes to an Approved NDA or ANDA (PDF - 108 KB)     Final    4/2004
Classifying Resubmissions in Response to Action       Final    5/14/1998
 Letters (PDF - 76 KB)
Enforcement Policy During Implementation of Section   Final    Withdrawn
 503A of the Federal Food, Drug, and Cosmetic Act              9/2008
Fast Track Drug Development Programs - Designation,   Final    11/17/
 Development, and Application Review (PDF - 311 KB)             1998
 (Posted 7/22/2004)
 Appendix 2 [(PDF - 3930 KB)] [Appendices are
 scanned copies, which will be replaced by final
 versions]
Formal Dispute Resolution: Appeals Above the          Final    2/2000
 Division Level(PDF - 30 KB)
Formal Meetings With Sponsors and Applicants for      Final    5/19/2009
 PDUFA Products (PDF - 89 KB)

Implementation of Section 120 of the Food and Drug    Final    10/1998
 Administration Modernization Act of 1997-Advisory
 Committees (PDF - 62 KB)
Implementation of Section 126 of the Food and Drug    Final    7/1998
 Administration Modernization Act of 1997 -
 Elimination of Certain Labeling Requirements (PDF -
 979 KB)
Information Program on Clinical Trials for Serious    Final    3/2002
 or Life-Threatening Diseases and Conditions(PDF -
 34 KB)
Information Program on Clinical Trials for Serious    Draft    1/2004
 or Life-Threatening Diseases and Conditions (PDF -
 40 KB)
National Uniformity for Nonpresciption Drugs -        Final    4/1998
 Ingredient Listing for OTC Drugs (PDF - 74 KB)
PET Drug Applications - Content and Format for NDAs   Draft    3/7/2000
 and ANDAs (PDF - 153 KB)
   Sample formats for chemistry,              .......  .........
   manufacturing, and controls sections (PDF - 125
   KB)
   Sample formats for labeling (PDF - 94 KB)  .......  .........
   Sample formats for Form FDA 356h (PDF -    .......  .........
   51 KB)
   Sample formats for user fee Form FDA       .......  .........
   3397(PDF - 42 KB)
Providing Clinical Evidence of Effectiveness for      Final    5/14/1998
 Human Drug and Biological Products (PDF - 129 KB)
Qualifying for Pediatric Exclusivity Under Section    Final    9/1999
 505A of the Federal Food, Drug, and Cosmetic Act
 (PDF - 57 KB)
   Frequently Asked Questions on Pediatric    .......  Posted
   Exclusivity (505A), The Pediatric ``Rule,'' and             7/27/1999
   Their Interaction
Repeal of Section 507 of the Federal Food, Drug and   Final    Revised
 Cosmetic Act (PDF - 85 KB)                                    5/1998
Reports on the Status of Postmarketing Study          Final    2/15/2006
 Commitments--Implementation of Section 130 of the
 Food and Drug Administration Modernization Act of
 1997 (PDF - 456 KB)
Standards for Prompt Review of Efficacy Supplements   Final    5/15/1998
 (PDF - 76 KB)
Submission of Abbreviated Reports and Synopses in     Final    8/1998
 Support of Marketing Applications (PDF - 43 KB)
Submitting and Reviewing Complete Responses to        Final    10/2000
 Clinical Holds (Revised) (PDF - 26 KB)
Over-the-Counter
Enforcement Policy on Marketing OTC Combination       Final    5/1984
 Products (CPG 7132b.16)(PDF - 294 KB)
General Guidelines for OTC Combination Products (PDF  Final    11/1978
 - 270 KB)
Label Comprehension Studies for Nonprescription Drug  Draft    4/30/2009
 Products (PDF - 204 KB)
Labeling Guidance for OTC Topical Drug Products for   Draft    6/1998
 the Treatment of Vaginal Yeast Infections
 (Vulvovaginal Candidiasis) (PDF - 71 KB)
Labeling OTC Human Drug Products--Questions and       Final    1/2/2009
 Answers (PDF - 599 KB)
Labeling OTC Human Drug Products -Submitting          Draft    12/2000
 Requests for Exemptions and Deferrals (PDF - 34 KB)
Labeling OTC Human Drug Products; Small Entity        Final    5/12/2009
 Compliance Guide (PDF - 270 KB)
Labeling OTC Human Drug Products Updating Labeling    Draft    2/21/2001
 in ANDAs (PDF - 32 KB)
   Additional examples 1 (PDF - 32 KB) (3/19/ .......  .........
   2001)
   Additional examples 2 (PDF - 15 KB) (3/26/ .......  .........
   2001)
   Additional examples 3 (PDF - 17 KB) (3/26/ .......  .........
   2001)
Labeling OTC Human Drug Products Updating Labeling    Final    10/2002
 in RLDs and ANDAs (PDF - 30 KB)
Example Drug Facts Labels
   Acetaminophen 120 mg in a Suppository      .......  .........
   Dosage Form (PDF - 13 KB)
   Acetaminophen 325 mg in a Suppository      .......  .........
   Dosage Form (PDF - 14 KB)
   Acetaminophen 650 mg in a Suppository      .......  .........
   Dosage Form (PDF - 14 KB)
   Cimetidine 200 mg in a Tablet Dosage Form  .......  .........
   (PDF - 13 KB)
   Clemastine Fumerate 1.34 mg in a Tablet    .......  .........
   Dosage Form(PDF - 14 KB)
   Doxylamine Succinate 25 mg Tablet Dosage   .......  .........
   Form (PDF - 12 KB)
   Ibuprofen 200 mg in a Tablet/Capsule       .......  .........
   Dosage Form (PDF - 14 KB)
   Loperamide HCl in a Liquid Dosage Form     .......  .........
   (PDF - 15 KB)
   Loperamide HCl in a Tablet/Caplet Dosage   .......  .........
   Form (PDF - 15 KB)
   Miconazole Nitrate Vaginal Products (PDF - .......  .........
    16 KB)
   Minoxidil Topical Solution 2% for Men and  .......  .........
   Women (PDF - 14 KB)
   Minoxidil Topical Solution 5% for Men      .......  .........
   (PDF - 17 KB)
   Naproxen Sodium 220 mg in a Tablet/Caplet/ .......  .........
   Gelcap Dosage Form (PDF - 14 KB)
   Pseudoephedrine HCl Extended-Release       .......  .........
   Tablets 120 mg (PDF - 15 KB)
Labeling OTC Human Drug Products Using a Column       Final    12/2000
 Format (PDF - 57 KB)
Labeling OTC Skin Protectant Drug Products (PDF -     Draft    Removed
 274 KB)                                                       3/18/2010
Postmarketing Adverse Event Reporting for             Final    7/13/2009
 Nonprescription Human Drug Products Marketed
 Without an Approved Application (PDF - 298 KB)
Labeling of Nonprescription Human Drug Products       Final    8/31/2009
 Marketed Without an Approved Application as
 Required by the Dietary Supplement and
 Nonprescription Drug Consumer Protection Act:
 Questions and Answers (PDF - 83 KB)
Time and Extent Applications (PDF - 46 KB)            Draft    2/2004
Upgrading Category III Antiperspirants to Category I  Final    10/1978
 (43 FR 46728-46731) (PDF - 583 KB)
Pharmacology/Toxicology
Animal Models--Essential Elements to Address          Draft    1/16/2009
 Efficacy Under the Animal Rule (PDF - 135 KB)
Carcinogenicity Study Protocol Submissions (PDF - 29  Final    5/22/2002
 KB)
Content and Format of Investigational New Drug        Final    11/1995
 Applications (INDs) for Phase 1 Studies of Drugs,
 Including Well-Characterized, Therapeutic,
 Biotechnology-derived Products (PDF - 42 KB)
   Questions and Answers: Content and Format  .......  .........
   of INDs for Phase 1 Studies of Drugs, Including
   Well-Characterized, Therapeutic, Biotechnology-
   Derived Products (PDF - 14 KB) (10/2000)
Developing Medical Imaging Drug and Biological        Final    6/17/2004
 Products
   Part 1: Conducting Safety Assessments      .......  .........
   (PDF - 271 KB)

Estimating the Maximum Safe Starting Dose in Initial  Final    7/21/2005
 Clinical Trials for Therapeutics in Adult Healthy
 Volunteers (PDF - 702 KB)
Exploratory IND Studies (PDF - 220 KB)                Final    1/12/2006
Format and Content of the Nonclinical Pharmacology/   Final    2/1987
 Toxicology Section of an Application* (PDF -1300
 KB)
Genotoxic and Carcinogenic Impurities in Drug         Draft    12/15/
 Substances and Products: Recommended Approaches                2008
 (PDF - 169 KB)
Immunotoxicology Evaluation of Investigational New    Final    10/2002
 Drugs (PDF - 100 KB)
Integration of Study Results to Assess Concerns       Draft    11/2001
 about Human Reproductive and Developmental
 Toxicities (PDF - 142 KB) (Issued , Posted 11/9/
 2001)
Nonclinical Evaluation of Late Radiation Toxicity of  Draft    6/17/2005
 Therapeutic Radiopharmaceuticals (PDF - 233 KB)
Nonclinical Pharmacology/Toxicology Development of    Final    10/96
 Topical Drugs Intended to Prevent the Transmission            Updated
 of Sexually Transmitted Diseases (STD) and/or for             7/2005
 the Development of Drugs Intended to Act as Vaginal
 Contraceptives
Nonclinical Safety Evaluation of Drug or Biologic     Final    3/14/2006
 Combinations (PDF - 100 KB)
Nonclinical Safety Evaluation of Reformulated Drug    Draft    3/7/2008
 Products and Products Intended for Administration
 by an Alternate Route (PDF - 76 KB)
Nonclinical Safety Evaluation of Pediatric Drug       Final    2/14/2006
 Products (PDF - 479 KB)
Nonclinical Studies for the Safety Evaluation of      Final    05/18/
 Pharmaceutical Excipients(PDF - 230 KB)                        2005
Photosafety Testing (PDF - 179 KB)                    Final    5/7/2003
Recommended Approaches to Integration of Genetic      Final    1/3/2006
 Toxicology Study Results (PDF - 190 KB)
Reference Guide for the Nonclinical Toxicity Studies  Final    3/2/1998
 of Antivial Drugs Indicated for the Treatment of N/
 A Non-Life Threatening Disease Evaluation of Drug
 Toxicity Prior to Phase I Clinical Studies (PDF -
 837 KB)
Safety Testing of Drug Metabolites (PDF - 86 KB)      Final    2/14/2008
Single Dose Acute Toxicity Testing for                Final    8/1996
 Pharmaceuticals (PDF - 63 KB)
Statistical Aspects of the Design, Analysis, and      Draft    5/2001
 Interpretation of Chronic Rodent Carcinogenicity
 Studies of Pharmaceuticals (PDF - 135 KB)
Procedural