drug-development
Every record this desk has filed under drug-development, newest first, each with the number of sources it can still show you.
FDA opened applications for a pilot meant to shorten the road to a first-in-human drug trial. Eight to ten pairs get in, the window closes October 30, and the agency keeps every power it had.
On September 15 the FDA announced the final design of its Expedited Investigational New Drug Pilot and began accepting applications. Drug sponsors apply paired with a qualified research institution; the FDA will review and accept individual components of an IND application on a rolling basis during the pre-IND phase rather than waiting for the whole package, with the aim of finding problems early enough to avoid a clinical hold during the 30-day IND period. The agency says first-in-human trials 'may take up to two years to complete in the United States' and are finished faster in China and Australia. Applications close October 30, 2026; the FDA expects 8-10 sponsor-institution pairs in the first cohort, and states it retains full regulatory authority throughout, including whether a trial may proceed.
Also filed underfdaclinical-trialsdeadlinehealth
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