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# FDA Pilots Speedier Reviews for U.S.-Made Generics
- URL: https://www.fdaweb.com/fda-pilots-speedier-reviews-for-u-s-made-generics/
- Published: 2025-10-03T12:00:00.000Z
- Updated: 2026-09-14T15:23:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159982

FDA has unveiled a new pilot program to prioritize the review of certain generic drug ANDAs in an effort to boost domestic pharmaceutical manufacturing and testing. The initiative will give faster review timelines to generic drugmakers that conduct bioequivalence testing in the United States and manufacture products domestically using U.S.-sourced active pharmaceutical ingredients (APIs). The goal is to strengthen the resilience of the U.S. drug supply chain and reduce reliance on foreign production, which currently dominates the market, an [agency notice](https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-new-anda-prioritization-pilot-support-us-generic-drug-manufacturing-and-testing?utm%5Fmedium=email&utm%5Fsource=govdelivery) says.

As of 2025, only 9% of API manufacturers are located in the U.S., compared with 22% in China and 44% in India, FDA says, adding that more than half of finished pharmaceuticals sold in the U.S. are produced abroad. “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,” CDER director **George Tidmarsh** is quoted in the notice as saying.

Tidmarsh also notes that foreign facility inspections add costs and delays to the regulatory process, while domestic oversight can be more efficient. The pilot, he says, is intended to provide incentives for companies to invest in U.S.-based operations.

Under the new pilot, ANDA applicants may request priority review if they meet three criteria: bioequivalence testing conducted in the U.S. (or a waiver), a U.S.-based manufacturing site for the finished drug, and a U.S.-based API supplier. Companies must follow the procedures in FDA’s Manual of Policies and Procedures 5240.3 and cite the pilot as their basis for prioritization.