MedCity News October 5, 2025
The FDA will provide faster regulatory review of generic drugs that are tested in and manufactured in the U.S. using domestically sourced active pharmaceutical ingredients. This FDA pilot program is part of a broader Trump administration strategy to reshore pharmaceutical production.
Big pharmaceutical companies are boosting their production capacity of branded pharmaceutical products with billions of dollars in new U.S. manufacturing plant construction, but generic drug production still remains mostly overseas. The FDA is addressing this imbalance through a new pilot program that incentivizes domestic manufacturing of generic drugs by speeding up the regulatory review of these medicines.
Under the new pilot program announced Friday, eligible drugmakers must source the ingredients and make the finished drug product within U.S. borders....
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