FDA launches expedited clinical trial application pilot

15th September 2026

Summary: The US Food and Drug Administration (FDA) has announced the final design of its Expedited Investigational New Drug (IND) Pilot and opened applications for participation. The programme aims to reduce the time required to initiate first-in-human clinical trials by pairing pharmaceutical sponsors with qualified research institutions that can support efficient preparation of IND applications. The FDA expects to select eight to ten sponsor-institution partnerships for the initial pilot, with applications closing on 30th October 2026. The initiative seeks to accelerate clinical research while maintaining regulatory standards and scientific oversight.

Link: https://www.fda.gov/news-events/press-announcements/fda-launches-expedited-ind-pilot-begins-accepting-applications

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