2006: A Regulatory Odyssey

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Special Issues

LCGC Supplements, Special Issues-07-01-2006, Volume 0, Issue 0

The regulatory environment is changing and is starting to sweep away some of the commandments on which we have relied, and to change others almost unrecognizably. To make the transition, FDA will have to reinvent itself and industry will have to rethink the way we develop and manage our processes.