FDA Announces New ANDA Prioritization Pilot To Support U.S. Generic Drug Manufacturing And Testing

Today, the U.S. Food and Drug Administration (FDA) is announcing a new pilot prioritization program for the review of abbreviated new drug applications (ANDAs) that aims to spur and reward investment in U.S. drug manufacturing and research and development and strengthen the domestic pharmaceutical supply chain by providing faster reviews for generic companies who test and manufacture their products in the U.S. 

More than half of pharmaceuticals distributed in the U.S. are manufactured overseas. Further, the U.S. is reliant on overseas sources for active pharmaceutical ingredients (APIs). As of 2025, only 9% of API manufacturers are in the U.S., compared to 22% in China and 44% in India. In addition, pivotal studies for drugs, including bioequivalence testing for generic drugs, are increasingly conducted outside the U.S., weakening the U.S.’s pharmaceutical research and development infrastructure.

“Ensuring that Americans have access to high-quality, safe and effective generic medicines is critical to public health. Overreliance on foreign drug manufacturing and testing creates risks both to national security and patient access, and undermines investments in U.S. research, manufacturing and production,” said Dr. George Tidmarsh, M.D., Ph.D., Director of FDA’s Center for Drug Evaluation and Research. “It also slows down reviews and costs taxpayers more money, as these foreign research and testing sites must be inspected by FDA, and foreign inspections take more time to prepare for and are more expensive to conduct than domestic inspections. This pilot prioritization program can help ensure that Americans have a strong and resilient domestic drug supply, and also reflects the Trump Administration’s unwavering commitment to revitalizing American industry and providing American consumers affordable access to needed medications.”

Earlier this week, FDA hosted a public meeting titled “Onshoring Manufacturing of Drugs and Biological Products” on FDA’s PreCheck program, which introduces an innovative two-phase approach to accelerate the establishment of high priority new pharmaceutical manufacturing facilities in the U.S. and strengthen the domestic pharmaceutical supply chain. At that meeting, FDA heard from stakeholders about how incentives such as faster reviews could spur additional investment in U.S. manufacturing and research and development.

This ANDA prioritization pilot represents a further step FDA is taking to incentivize U.S. generic drug manufacturing and testing. Under this pilot, ANDA applicants who conduct any required bioequivalence testing in the United States and whose products are made in the U.S. using exclusively domestic sources for APIs are eligible for priority review. Applicants can request this priority review 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 (“Prioritization MAPP”) and referencing this pilot program as the basis for prioritization. Applicants should provide information with their priority review request to demonstrate that their ANDA qualifies for the pilot (i.e., (1) that either the pivotal bioequivalence testing was conducted in the U.S. or that the ANDA qualifies for a waiver of bioequivalence testing, (2) that the finished dosage form manufacturer is located in the U.S., and (3) that the API supplier is located in the U.S.). Prioritizing this additional category of ANDAs is expected to expedite the availability of high-quality, U.S.-made generics for American consumers.