pharmaphorum October 5, 2025
In another move designed to reduce the US’s reliance on imported medicines, the FDA has launched a pilot of fast-track reviews for generics tested and made in domestic facilities.
According to the regulator, applicants who conduct any required bioequivalence testing in the US, and whose products are made there using exclusively domestic sources for active pharmaceutical ingredients (APIs), will be eligible for priority review.
In a statement announcing the scheme, the FDA said that more than half of the pharmaceuticals distributed in the US are manufactured overseas, while only 9% of APIs are produced domestically. China supplies around 22% of the API market, and India supplies 44%.
Meanwhile, studies of generics, including bioequivalency testing, are increasingly being carried out outside...
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