FDA Opens Pilot to Speed Drug Testing Timelines — SkimNews
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- The FDA opened applications Tuesday for a pilot program designed to shorten the time drugmakers need to begin testing products in humans.
- Operation TrialBlazer, the HHS initiative behind the pilot, was first announced in June and pledged to compress FDA drug approval timelines.
- HHS wrote in the TrialBlazer roadmap that "the U.S. pathway can be measured in years, while other countries' pathways are measured in months."
- The initiative explicitly aims to help the U.S. compete with the rapidly accelerating biotechnology industries in China and Australia.
Why it matters: Drugmakers accepted into the pilot could shave years off the U.S. path to human testing, directly addressing HHS's own stated concern that U.S. timelines stretch into years while competitors in China and Australia work in months — a rare on-the-record acknowledgment of how much ground U.S. biotech has ceded.
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