CureDuchenne and PPMD Announce Webinar on FDA, Medical Product Regulation, and Advocate Involvement
Published: Jun 17, 2010
CORONA DEL MAR, Calif.--(BUSINESS WIRE)--How does the FDA make its decisions? Who makes the rules for drug development? What special accommodations are made for rare diseases? Cure Duchenne and Parent Project Muscular Dystrophy are happy to bring you this two-part live Webinar series featuring Dr. David Banks of the FDA Office of Special Health Issues. Dr. Banks will walk us through the general steps required for approving a drug with special emphasis on the implications of the Orphan Drug Act, individual INDS and expanded access programs. This series is meant to be interactive—participants can either type in questions that will be displayed during the discussion or submit questions in advance. These talks will attempt to provide some insights into the FDA’s mission--what are its constraints, and what are its goals? Dr. Banks will not be able to address questions about specific therapeutics that are undergoing regulatory review right now, but can talk about general principles and how they might be applied. The topics in the two series will be different.