FDA's CBER chief outlines a pilot to fast-track Phase 1 trials, pairing sponsors with vetted research institutions; applications open in September.
As the debate over how the US can better compete with China on drug development rolls on, the FDA is detailing plans for an expedited …
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Federal health officials aim to speed up drug development and better compete with China.
New initiative aims to shorten timelines from early-stage research to late-stage clinical trials through regulatory reforms.
A series of newly planned reforms are designed to entice companies to start early trials in the U.S. rather than overseas.
FDA will end its CMC Development and Readiness Pilot in April 2027 after low participation — only 21 of 27 expected drugmakers…
FDA names seven companies to its PreCheck pilot to speed U.S. drug manufacturing reviews after receiving more than 80…
Monitoring trials in real time may help shorten the time interval between trial phases.
