New ANDA Prioritization Pilot to Support US Generic Drug Manufacturing and Testing
On October 3, 2025, the FDA launched a new pilot prioritization program for ANDA (Abbreviated New Drug Application) reviews to strengthen the US pharmaceutical supply chain and incentivize domestic manufacturing and research. The program offers priority (faster) reviews for generic drug applicants that conduct bioequivalence testing and manufacture their finished dosage forms in the United States using domestically sourced active pharmaceutical ingredients (APIs). This initiative is designed to spur investment in US-based production and testing, reduce reliance on foreign suppliers, and ensure a more secure, cost-effective, and resilient drug supply. Currently, only about 9% of API manufacturers are in the U.S., compared to 22% in China and 44% in India, highlighting the nation’s dependence on overseas production.
FDA officials, including Dr. George Tidmarsh, Director of FDA’s Center for Drug Evaluation and Research, emphasized that foreign manufacturing dependence increases national security and patient access risks, and raises costs because foreign facilities require more complex and expensive inspections. The new program complements FDA’s broader “Onshoring Manufacturing of Drugs and Biological Products” and PreCheck initiatives, which aim to accelerate establishment of domestic manufacturing sites.
Applicants seeking this priority review can do so by following the procedures outlined in FDA’s Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements and by referencing this pilot program as the basis for prioritization. They must also demonstrate that their ANDA qualifies for the pilot by showing that:
- Either the pivotal bioequivalence testing was conducted in the US or the ANDA qualifies for a waiver of bioequivalence testing;
- The finished dosage form manufacturer is located in the US; and
- The API supplier is located in the US.
By prioritizing review of such ANDAs, FDA expects to accelerate approval of high-quality, US-made generics and reinforce national efforts to revitalize domestic pharmaceutical manufacturing and research capacity.