On September 15, 2026, the FDA opened applications for an Expedited Investigational New Drug (IND) Pilot Program aimed at speeding up first-in-human Phase 1 trials.
The program will pair drug developers with selected Qualified Research Institutions, including academic medical centers, contract research organizations and regulatory experts.
Sponsors may submit IND components incrementally, allowing the FDA to review them on a rolling basis instead of waiting for a complete application.
The FDA expects to select roughly eight to 10 sponsor–institution partnerships. Applications are due by October 30, 2026.
The agency says the initiative could cut six to 12 months from early drug-development timelines, while maintaining existing safety and scientific oversight.
The pilot is part of the broader HHS Operation TrialBlazer initiative, which seeks to make U.S. clinical research faster and more competitive with programs in countries such as China and Australia.
The FDA will prioritize novel treatments for serious diseases with major unmet medical needs and sponsors that already have sufficient preclinical data.
Sources:
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