Lexology October 16, 2025
On October 3, 2025, the U.S. Food and Drug Administration (FDA) unveiled a pilot prioritization program that provides for accelerated review of abbreviated new drug applications (ANDAs) for generic companies that test and manufacture their products in the United States.[1] The aim of the program is to “spur and reward investment in U.S. drug manufacturing and research and development and strengthen the domestic pharmaceutical supply chain….”[2] According to the FDA, “[m]ore than half of pharmaceuticals distributed in the U.S. are manufactured overseas[,]” and “only 9% of API manufacturers are in the U.S., compared to 22% in China and 44% in India.”[3]
In general, in order to demonstrate that its ANDA qualifies for the pilot program, a generic company must submit...
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