FDA Town Hall

6:00 AM - 7:15 AM (PDT), Thursday, June 11, 2020
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The session will be organized as an interactive, moderated roundtable discussion of FDA center priorities followed by a question-and-answer session with the audience. Topics that will be addressed during the roundtable will 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.
Moderator
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Chairman & CEO
Alkermes, Inc.
Speakers
Peter Marks
Director, Centers for Biologics Evaluation & Research
US Food & Drug Administration
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Chairman & CEO
Alkermes, Inc.
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Director, Office of New Drugs, Center for Drug Evaluation and Research
U.S. Food and Drug Administration (FDA)