On Oct. 3, 2025, the U.S. Food and Drug Administration (FDA) announced 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.

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.