FDA: keynote address, PDA/FDA conference.
In the beginning of my presentation, I alluded to the breadth of issues and change facing FDA and, in particular, the office of regulatory affairs. I hope you now have a feel for the changing times that you face with the FDA. I hope that FDA's persistence and investigative thoroughness inspires a greater concern for compliance by industry officials. FDA's reliance in "voluntary compliance," and the public's protection afforded by it, are dependent on industry's appreciation of the alternatives to voluntary compliance.
Chesemore
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Food and Drug Administration.
D001709:Biotechnology; D004345:Drug Industry / Q000331:legislation & jurisprudence; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D007373:Interinstitutional Relations; D007880:Legislation, Drug; D011358:Product Surveillance, Postmarketing; D012957:Societies, Pharmaceutical; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration