The Food and Drug Administration on Sept. 15 released the final design of its Expedited Investigational New Drug (IND) Pilot and began accepting applications from drugmakers and research partners. Drug sponsors and qualified research institutions must apply as pairs by Oct. 30, 2026, and the agency expects to select eight to 10 pairs for its first group.
Update Note: This article reports new information on the FDA's Expedited IND Pilot following MedicalDaily's earlier coverage of the proposal's public comment period. The latest verified information comes from the FDA's announcement dated Sept. 15, 2026.
