Watch the Recorded Webinar: Understanding and Maximizing Interactions with the Califf FDA
Dr. Robert Califf’s confirmation as FDA Commissioner will shape the future of American healthcare. So what should the biopharma industry expect and how can companies prepare?
YourEncore policy experts Peter J. Pitts, former FDA Associate Commissioner, and Dr. Tim Franson, immediate Past President of USP, will outline likely key areas of focus for the Califf administration and their impact on your business planning.
Innovation and review strategies
Post marketing safety
Should you brace for impact or embrace for impact? Our experts will help you answer that question.
Peter J. Pitts – Executive Partner for YourEncore, former FDA Associate Commissioner, current Chief Regulatory Officer for Adherent Health Strategies and Founder/President of the Center for Medicine in the Public Interest.
Dr. Tim Franson – Chief Medical Officer for YourEncore, Board Member for the Critical Path Institute, and Immediate Past President of the USP Convention. Dr. Franson was also a key contributor to PDUFA V and co-authored the first-ever patient advocacy-initiated guidance for a rare disease submitted to FDA in 2014.
[WEBINAR] Alternative Regulatory Pathways for Rare Disease: Breaking the ICE
Keynote Speaker: Tim Franson, M.D.
Moderator: Joseph Lamendola, Ph.D.
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With the upcoming PDUFA renewal, 21st Century Cures uncertainty, and a leadership transition at FDA, it is ...