New ANDA prioritization pilot to support US generic drugs

4 October 2025

The US Food and Drug Administration (FDA) announced a new prioritization pilot program for abbreviated new drug applications (ANDAs) that aims to spur and reward investment in US 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 USA.

Earlier this week, the 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 USA and strengthen the domestic pharmaceutical supply chain. At that meeting, the FDA heard from stakeholders about how incentives such as faster reviews could spur additional investment in US manufacturing and research and development.

Huge amount of generics imported

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