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.