India, Sept. 15 -- The U.S. Food and Drug Administration has unveiled the final design of its Expedited Investigational New Drug (IND) Pilot, a new program intended to shorten the time it takes for drug developers to move from discovery to first-in-human clinical trials.
The agency has begun accepting applications, with the submission window open until October 30, 2026.
The pilot aims to reduce delays in early-stage drug development by pairing participating companies with qualified research institutions (QRIs) that bring specialized scientific and regulatory expertise. These QRIs will help prepare IND components for rolling review, allowing the FDA to evaluate sections as they are completed rather than waiting for a full application.
The...