Understanding and Maximizing Interactions with the Califf FDA

March 17, 2016 Peter J. Pitts



image source: fda.gov

Does it really matter who sits in the corner office at the FDA?

Isn’t PDUFA VI already a done deal?

Can one person really change the direction of an agency that is almost entirely staffed by career civil servants?

Why bother with a new Commissioner with only one year left in the Administration?

These are all good questions, and the right answers depend on specifically who is leading the FDA.  Thanks to his recent confirmation, we now know that man is Dr. Robert Califf.

For some answers, insights, and prognostications to the questions above, I sat down with Dr. Tim Franson, Chief Medical Officer of YourEncore, to discuss what industry can expect and how to maximize future FDA interactions. 

Listen to the 40 minute discussion.  It’ll be 40-minutes well spent.


Peter J. Pitts  is an authority on global regulatory policy issues and an Executive Partner at YourEncore. He is a former FDA Associate Commissioner, the Chief Regulatory Officer for Adherent Health Strategies, and the President of the Center for Medicine in the Public Interest, a policy institute he founded in 2004.

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