Review of FDA Regulatory Trends in 2009

I was reading through some FDA literature on the web when I came across this excellent review of how to prepare for a FDA regulatory review and some expected enforcement trends for 2009  and beyond.  The presentation is available at no cost with a recording, transcript and slideshow in its entirety from Joseph M Pickett President of ExpertBriefings.

Of particular interest to the manufacturing community is the prediction that things are about to get more stringent as a result of the change in administration. Details are given in the presentation. Here are a few John Avellanet quotes from the transcript.

“I think we will all see an aggressive stance in the second half of the
year, quite clearly. And I think that second half aggressive stance is really going to be epitomized by Dr. Wolfe there, who has been a very vocal critic of the industry and is now on the Drug Safety and Risk Management committee there at the FDA.”

“The routine inspections, these are the ones that theoretically are supposed to happen every two years. The reality is, the agency bases it on risk for a variety of reasons. High risk firms get 2-3 years, medium risk gets 4-5, and low risk firms get 7-9.”

“If any of your executives have previous problems with the FDA, I can guarantee you that your pre-approval on your for-cause inspection will blow up into a big giant inspection once they realize who they executives are.”

For free slides and transcript of the 2/17/09 teleconference “Bulletproof Yourself Against FDA Enforcement in 2009” featuring John Avellanet, Cerulean Associates LLC, please email Joseph Pickett at:  communications@

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