FDA opens pilot program to speed human testing of new drugs
The Food and Drug Administration announced it is accepting applications for a pilot under Operation TrialBlazer aimed at reducing the time before drug candidates can start human trials.
The initiative seeks to make U.S. timelines comparable to those in China and Australia, where approvals can take months rather than years.
First mentioned in June, the program will let participating companies test products in humans more quickly, though details on eligibility and duration were not provided.
The move reflects a broader HHS effort to accelerate biotech development and keep the United States competitive.
This writeup was produced by pharmadog from original reporting by STAT.
Original headline: “STAT+: FDA takes applications for new program to shorten drug approval times”
read at STAT ↗
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