FDA Sets Application Instructions for Expedited IND Pilot Program
Start here
The FDA has issued application instructions for its Expedited Investigational New Drug (IND) Pilot Program. Sponsors and prospective Qualified Research Institutions each complete a form, and the sponsor submits both through the FDA ESG Gateway as a single package. The application window remains open for 45 days, with possible extension. FDA scientific experts will review submissions and select 8 to 10 Sponsor-QRI pairs. The agency will not broker matches: participating parties must form their business relationship outside the FDA, which will only confirm that an official agreement exists. The selection of the Sponsor-QRI pairs is still ahead.
Written by a model from the reports · updated 11 days ago
Coverage timeline
Follow the coverage to see the different angles.
- fda.govPickExpedited Investigational New Drug Pilot Program - Application Instructions
The FDA has issued application instructions for its Expedited IND Pilot Program. Sponsors and prospective Qualified Research Institutions each complete a form, then the sponsor submits both through the FDA ESG Gateway as one package. The application window stays open for 45 days with possible extension, and FDA scientific experts will review submissions and select 8 to 10 Sponsor-QRI pairs. Participating parties must form their business relationship outside FDA, which will only confirm that an official agreement exists.