fda.gov· FDA·· 4 hours agoPickScore65
FDA Expedited Investigational New Drug (IND) Pilot Program
FDA Expedited Investigational New Drug (IND) Pilot Program
In brief
The FDA has launched the Expedited IND Pilot Program under HHS Operation TrialBlazer to test ways of shortening the path from IND-enabling activities to first-in-human trials in the US. Sponsors partnering voluntarily with qualified research institutions, which advise on toxicology, clinical and CMC components, can submit IND pieces for rolling FDA review rather than waiting for a complete package. FDA retains full regulatory authority, and the pilot's evidence may shape future policy such as accreditation of these institutions.
Why it matters
FDA is testing rolling IND review with outside experts, a change that could alter timelines for early-stage US drug development.
Source: fda.gov · fda.gov