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Watch the above video of a moderated roundtable discussion of FDA center priorities, followed by a question-and-answer session with the audience. Topics that are addressed during the roundtable include the FDA’s perspectives on critical topics such as PDUFA VI implementation and potential areas for focus for PDUFA VII; efforts to advance innovation and expedite patient access to novel therapies for serious and life-threatening conditions; novel approaches to integrating new scientific tools into FDA regulatory practices at all levels; and FDA resources and scientific infrastructure.


  • Richard Pops, Chairman & CEO, Alkermes, Inc.
  • Peter Marks, MD, PhD, Director, Centers for Biologics Evaluation & Research, US Food & Drug Administration
  • Peter Stein, Director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA)