By Frederick R. Ball, Coleen W. Hill and Kelechi Anyatonwu
The U.S. Food and Drug Administration (FDA) recently announced the final design of its much-anticipated Expedited Investigational New Drug Pilot Program. To participate in the program, sponsors and prospective Qualified Research Institutions (QRIs) may submit applications until October 30, 2026, and the FDA will select its cohort of Pilot Program participants by December 18, 2026. Timelines may vary depending on the number of submissions FDA receives. The FDA expects to select eight to 10 sponsor-QRI pairs for the initial pilot cohort.