The U.S. Food and Drug Administration (FDA) is responsible for “the safety and efficacy” of biologic products and medical devices, along with other veterinary, food supply, and cosmetic products that are marketed or sold in the U.S. It carries out this authority by reviewing manufacturers’ applications to sell these items in the United States.
During this session, panelists provided an overview of the role of the FDA particularly focusing on the approval process required to bring new medical products to market. The session reviewed 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 also shared insights about the FDA’s role in new drug approval within the context of other federal agencies.
- Clay Alspach, J.D., Principal, Leavitt Partners
- Kelly George, Ph.D., RAC, Principal, Regulatory Strategy and FDA Policy, Avalere Health
- Reshma Ramachandran, M.D., MPP, Physician-Fellow, Yale School of Medicine
- Ameet Sarpatwari, Ph.D., J.D., Assistant Professor of Medicine, Harvard Medical School
- Marta Wosińska, Ph.D., Visiting Fellow, USC-Brookings Schaeffer Initiative for Health Policy (moderator)
This event was made possible with support from Arnold Ventures.
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Clay Alspach, J.D.
Leavitt Partners, Principal
Kelly George, Ph.D.
Reshma Ramachandran, M.D. MPP
Yale School of Medicine, Physician- Fellow
Ameet Sarpatwari, Ph.D., J.D.
Assistant Professor of Medicine, Harvard Medical School
Associate Epidemiologist, Brigham and Women’s Hospital
Assistant Director, Program on Regulation, Therapeutics, And Law
Marta Wosińska, Ph.D.
Visiting Fellow, Brookings
Experts and Analysts
Kirsten Axelsen, M.S.
American Enterprise Institute, Nonresident Fellow
Craig Burns, Ph.D.
America’s Health Insurance Plan, Vice President of Research
Sean Dickson, J.D., MPH
West Health Policy Center, Director Health Policy
Stacie B. Dusetzina, Ph.D.
Vanderbilt University, Associate Professor Health Policy
Andrea Noda, MPP
Arnold Ventures, VP of Health Care- Drug Pricing
Rachel L. Sher, J.D. MPH
Kirk Williamson, M.A.
Arnold Ventures, Health Care Manager
Sally Choe, Ph.D.
FDA Center for Drug Evaluation and Research (CDER), Director of Generic Drugs
Nathan S. Ivey, Ph.D.
FDA, Regulatory Programs Staff
Erica Blake Payne, J.D.
FDA, Regulatory Council Office of Generic Drug Policy
Craig Burns, Ph.D.
Jasper Therapeutics, Vice President of Program Management
Heather Foster, MPH
Association for Community Affiliated Plans, Vice President of Marketplace Policy
Allison Herrity, MPH
National Organization for Rare Disorders, Policy Analyst
Mark Howell, J.D.
American Hospital Association, Director of Policy and Patient Safety
Christine Aguiar Lynch, MPH
Association for Community Affiliated Plans, Vice President of Medicare and MLTSS Policy
Monet Stanford, Pharm.D.
Association for Accessible Medicines, Director of Policy