what are the indication for
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Indication (medicine) In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery.[1] The opposite of an indication is a contraindication,[2] a reason to withhold a certain medical treatment because it could harm a patient.
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- Geographical Indications. Geographical Indications of Goods are defined as that aspect of industrial property which refer to the geographical indication referring to a country or to a place situated therein as being the country or place of origin of that product.eographical Indications. Geographical Indications of Goods are defined as that aspect of industrial property which refer to the geographical indication referring to a country or to a place situated therein as being the country or place of origin of that product.
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- • This MAPP describes the Office of Generic Drugs (OGD) policy and procedures for review of investigational new drug applications (INDs) submitted for bioavailability or bioequivalence studies under 21 CFR 320.31. As stated in 21 CFR 320.31(a), any sponsor planning to conduct an in vivo bioavailability or bioequivalence study in humans should submit a Bio-IND if: (1) The study involves a radioactive labeled drug product, or (2) The study involves a cytotoxic drug.
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Types of Applications Abbreviated New Drug Application (ANDA) An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
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- It allows you to calculateadherence rates separately for each type of indication andeach health care worker category (for example, nurses per-formed hand hygiene before patient care, 80% adherence;physicians performed hand hygiene after patient care, 80%adherence).
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- National Prescribing Service – www.nps.org.au. For the purpose of this policy, ‘medication authorisation form’ is the term used for parents or guardians to grant written consent for a service to administer medication to a child.
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indication Definition: The basis for initiation of a treatment for a disease or of a diagnostic test; may be furnished by a knowledge of the cause (causal indication), by the symptoms present (symptomatic indication), or by the nature of the disease (specific indication). [L. fr. in-dico, pp.
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Injection (medicine) Zoladex is an example of a medication delivered by depot for prostate cancer treatment or therapy. Naltrexone may be administered in a monthly depot injection to control opiod abuse; in this case, the depot injection improves compliance by replacing daily pill administration.
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"What does it mean when FDA ""clears"" or ""approves"" a medical device?" 1 clear the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA, or.  2 approve the device after reviewing a premarket approval (PMA) application that has been submitted to FDA.
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- Approval is based on medical. necessity as defined in the patient’s benefit plan or certificate. All benefits are subject to the terms, conditions, and exclusions. of the benefit plan or certificate. This may include policy language. regarding pre-existing conditions or signed affidavits stating. that the insurance bears no responsibility, as signed by the. insured.
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Food and Drug Administration For approval of a generic drug, the U.S. Food and Drug Administration (FDA) requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug. This is called an ANDA (Abbreviated New Drug Application).
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- Indicate: in DIC ate (in’ di kate) v. To point out; as, indicate an error 11. Indication: in DIC ation (in di kay’ shun) n. A sign of; as, an indication of favor 12. Indicator: in DIC ator (in’ di kate r) n.
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IMPD Guidance Substantial Amendment Notification Form (Cf. Section 3.7.b of the Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial).ate: To be filled in by the applicant: This form is to be used both for a request to the Competent Authority for authorisation of a. substantial. amendment and to an Ethics Committee for its opinion on a. substantial. amendment.
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Investigational New Drug Investigational New Drug. The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
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obstruction Extended Use or Prescription. One method of establishing a highway or public road is through prescription—the extended use of a piece of land for a certain length of time by the public, absent the owner's consent.
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indicator If you're familiar with the verb to indicate, then indicator should be no problem. An indicator points to, suggests, or shows something. The arrow on a street sign is an indicator telling you which way to go. It's not the heat, it's the humidity!. In other words, temperature is only one indicator of how it feels outside. Air-pressure, humidity, wind-chill, and cloud cover are other important indicators of weather conditions.
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New drug application Generic drugs that have already been approved via an NDA submitted by another maker are approved via an Abbreviated New Drug Application (ANDA), which does not require all of the clinical trials normally required for a new drug in an NDA.he documentation required in an NDA is supposed to tell the drug’s whole story, including what happened during clinical tests, what the ingredients of the drug formulation are, results of animal studies, how the drug behaves in the body, and how the company manufactures, processes and packages it.
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- The basis or rationale for using a particular treatment or diagnostic test; may be furnished by a knowledge of the cause (causal indication), by the symptoms present (symptomatic indication), or by the nature of the disease (specific indication). [L. fr. in-dico, pp.
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- 1 Risk factors may be an indication for investigation-particularly a full blood count-but are not in themselves an indication for antibiotics if the baby is born at term and is clinically well. 2  This is not a complete list and if there are any doubts a more senior member of staff should be consulted.
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- We consider the treatment of cUTIs to be an indication distinct from the treatment of. uncomplicated urinary tract infections. This guidance addresses cUTI only. Sponsors interested. in pursuing an indication for the treatment of uncomplicated urinary tract infections should.
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- Page 1 of 4 Copyright 2012 • Review Completed on 09/08/2012 Therapeutic Class Review Topical Analgesics and Anesthetics Therapeutic Class • Overview/Summary: The topical analgesics and anesthetics are approved by the Food and Drug Administration (FDA) for a variety of indications.
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Equestrianism Types of horse racing. Under saddle: Thoroughbred horse racing is the most popular form worldwide. In the UK, it is known as flat racing and is governed by the Jockey Club in the United Kingdom. In the USA, horse racing is governed by The Jockey Club. Steeplechasing involves racing on a track where the horses also jump over obstacles.
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Accelerated Approval For Patients. Accelerated Approval. When studying a new drug, it can sometimes take many years to learn whether a drug actually provides a real effect on how a patient survives, feels, or functions. A positive therapeutic effect that is clinically meaningful in the context of a given disease is known as “clinical benefit”. Mindful of the fact that it may take an extended period of time to measure a drug’s intended clinical benefit, in 1992 FDA instituted the Accelerated Approval regulations.
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Indication of tooth extraction Indication of tooth extraction. Indication of tooth extraction. 1) Indication of tooth extraction a) Severe caries The most common and widely accepted reason to remove a tooth is that it is severely carious that it cannot be restored. b) Pulpal necrosis Next is the presence of pulp necrosis or irreversible pulpitis that is not amenable to endodontics.
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Medical management and pharmacology updateUse of the Beers criteria to identify potentially inappropriate drug use by community-dwelling older dental patients The Beers criteria identifying potentially inappropriate drugs with a high risk for AEs were developed to address these issues and have been widely adopted to identify drugs that should be avoided in this population.