New Therapeutics: From an Idea to an Approved Therapy 

III. Navigating the FDA Approval Process

This talk provides an overview of the FDA approval process through case-based examples.

Learning objectives:

  1. Summarize the role of the FDA in evaluating and approving new medications
  2. Understand the importance of study design and endpoints
  3. Discuss special considerations related to approval of therapies with oral medicine indications
Fred Hyman, DDS, MPH
Food and Drug Administration

Center for Drug Evaluation and Research