FDA finalizes Expedited IND Pilot to speed first-in-human trials

Verifying
  • FDA finalized the Expedited IND Pilot for drug sponsors and qualified research institutions.
  • October 30, 2026, is the application deadline; 8–10 pairs are expected initially.
  • The pilot enables rolling pre-IND review while FDA retains full regulatory authority.
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FDA finalizes Expedited IND Pilot to speed first-in-human trials - CoinPost Terminal