FDA Launches Pilot Program to Prioritize U.S. Generic Drug Manufacturing and Testing
On October 3, 2025, the FDA announced a new pilot program that provides priority review for abbreviated new drug applications (ANDAs) for generic drugs that are both manufactured and tested entirely within the United States, using exclusively U.S.-sourced active pharmaceutical ingredients (APIs)1910.
The aim of the program is to incentivize domestic investment in drug manufacturing and research by offering faster approval for products made and tested entirely with U.S. materials and facilities2345.
As of 2025, only 9% of API manufacturers are located in the U.S., while most are based in China (22%) and India (44%), making eligibility for the program challenging in the current market1.
FDA officials state that the program is designed to strengthen the nation’s drug supply chain, reduce reliance on overseas suppliers, and increase access to high-quality generic medicines in the U.S.234.
The program is part of broader FDA efforts, including the new FDA PreCheck initiative, to encourage a resilient domestic pharmaceutical sector and improve patient access to affordable medications2678.
Sources:
1. https://www.lachmanconsultants.com/2025/10/fda-launches-anda-prioritization-pilot-can-it-be-helpful-today/
2. https://community.triblive.com/news/3891903
3. https://www.pharmexec.com/view/fda-domestic-generic-drug-fast-track-review-program
4. https://trial.medpath.com/news/dc578ea455758aa6/fda-launches-fast-track-review-program-for-u-s-made-generic-drugs-to-strengthen-supply-chain-resilience
5. https://www.biospace.com/fda/fda-continues-us-manufacturing-drive-with-domestic-generics-pilot
6. https://www.fda.gov/news-events/press-announcements/fda-announces-new-fda-precheck-program-boost-us-drug-manufacturing
7. https://www.fiercepharma.com/manufacturing/fda-launches-generics-pilot-program-takes-comments-facility-precheck-proposal-bid
8. https://www.aha.org/news/headline/2025-08-07-fda-announces-new-program-boost-domestic-drug-manufacturing
9. https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-new-anda-prioritization-pilot-support-us-generic-drug-manufacturing-and-testing
10. https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda