Understanding the Consequences of Risk-Based Regulation  Fri,
08/11/2006 - 5:20am  As the FDA embraces a new method for
managing compliance, FDA-regulated manufacturers can gain
insight by examining the experiences of the nuclear power
industry  ‘The move toward risk-informed regulation in FDA-
regulated sectors is likely to mean challenging conventional
wisdom.’  By Jonathan Coburn and Greg Weddle Just the Facts
About Regulation • The FDA is starting to implement a new risk-
based approach for delivering and managing compliance. • The
regulated community is grappling with what this risk-based
approach might mean and what implications might result. • The
precedent set by the nuclear power industry, where industry and
regulators faced similar questions, shows what consequences to
prepare for when adopting risk-based regulation. • By
understanding these consequences, FDA-regulated manufacturers
can make faster and more direct progress. The FDA has taken the
first steps toward implementing a new method of deliveri