FDA pilot aims to speed the first human tests of new drugs
Sept. 15, 2026 — The FDA has opened applications for a pilot program meant to speed first-in-human drug trials in the United States, which the agency says can take up to two years here but move much faster in China and Australia. Drug developers will team with qualified research institutions, such as academic medical centers or contract research organizations, and the FDA will review parts of their applications as they are ready rather than waiting for a full package. Applications are due Oct. 30, and the FDA expects to pick eight to 10 pairs by Dec. 18. The FDA says that when early trials move overseas, American patients lose the chance to take part and the agency loses influence over the science. The pilot is part of HHS's Operation TrialBlazer.
The wall: The two-year figure is the FDA's own; whether the pilot shortens timelines will not be known until the cohort is under way.
Tier: Confirmed (FDA rationale via trade summary)
Sources
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