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FDA pilot program aims to speed up early-stage clinical trials
statnews.com • • business
Key Points:
- Federal health officials announced a pilot program aimed at accelerating early-stage clinical trials, potentially cutting development timelines by six to 12 months.
- The initiative seeks to encourage more U.S.-based clinical trials and address China's growing dominance in the field.
- The FDA, through the president’s 2027 fiscal budget, is requesting Congress to create a permanent, expedited process for the Investigational New Drug pathway.
- The proposal was supported by former FDA Commissioner Marty Makary and has been in development since the beginning of the current administration.
