On October 3, 2025, the FDA launched a pilot prioritization program to speed up the review of abbreviated new drug applications (ANDAs) for companies that manufacture and test their products in the U.S. The program aims to boost domestic drug production and R&D while reducing reliance on foreign supply chains.

Currently, over half of U.S. pharmaceuticals are made overseas, with only 9% of active pharmaceutical ingredient (API) manufacturers based in the U.S., compared to 22% in China and 44% in India. Increasingly, key studies such as bioequivalence testing are also conducted abroad, weakening the nation’s pharmaceutical research infrastructure.

Dr. George Tidmarsh, Director of the FDA’s Center for Drug Evaluation and Research, emphasized that ensuring access to safe, effective, and affordable generic medicines is vital to public health. He noted that dependence on foreign manufacturing and testing poses risks to national security and patient access, while also increasing costs and delaying reviews due to the need for overseas inspections. The new pilot program, he added, aims to strengthen the U.S. drug supply chain and supports the administration’s commitment to revitalizing American industry and improving access to essential medications.

The FDA held a public meeting titled “Onshoring Manufacturing of Drugs and Biological Products” to discuss its PreCheck program, which aims to speed up the development of new U.S.-based pharmaceutical manufacturing facilities and strengthen the domestic drug supply chain. Stakeholders highlighted that incentives like faster reviews could encourage more investment in U.S. manufacturing and research.

Building on this effort, the FDA introduced a pilot program to prioritize the review of abbreviated new drug applications (ANDAs) for companies that conduct bioequivalence testing and manufacture their products entirely in the U.S. Applicants meeting these criteria—using U.S.-based facilities and domestic API sources can request priority review following FDA’s established procedures. This initiative is expected to accelerate the availability of high-quality, U.S.-made generic medicines for American patients.

Learn more: FDA Announces New ANDA Prioritization Pilot