FDA Approval Pathways 101

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.