FDA Approval Pathways 101

During this webinar, panelists will provide an overview of the role of the FDA particularly focusing on the approval process required to bring new medical products to market. The session will review the traditional stages the FDA takes to approve various types of new drugs, the various pathways for drugs to be rapidly approved, as well as how the FDA monitors safety in the post-market “fifth phase”. Panelists will also share insights about the FDA’s role in new drug approval within the context of other federal agencies, such as the U.S. Patent and Trademark Office (USPTO), Centers for Medicare and Medicaid Services (CMS), and the Federal Trade Commission (FTC).

Panelists:

• Clay Alspach, J.D., Leavitt Partners
• Kelly George, Ph.D., Avalere Health
• Reshma Ramachandran, M.D., Yale School of Medicine
• Marta Wosińska, Ph.D., USC-Brookings Schaeffer Initiative for Health Policy (moderator)