FDA Launches New ANDA Prioritization Pilot to Support U.S.-Based Generic Manufacturing

The U.S. Food and Drug Administration (FDA) has introduced a new pilot program to prioritize Abbreviated New Drug Applications (ANDAs) for generic drugs that utilize U.S.-based manufacturing and testing. Announced on October 3, 2025, this additional 
FDA initiative aims to strengthen the domestic pharmaceutical supply chain and reduce reliance on foreign sources. By offering expedited reviews, the ANDA prioritization pilot continues the FDA’s push to further incentivize investments in U.S. operations.

This ANDA pilot program aligns closely with the FDA's broader efforts to onshore drug production, including the recent September 30, 2025, public meeting where the FDA addressed the draft Pre-Check framework—a voluntary two-phase process for expediting approvals utilizing U.S. manufacturing facilities.  

Key features of the ANDA Prioritization Pilot Program include the following:

Eligibility: Eligibility for the program is based on three (3) key requirements:

1. Pivotal bioequivalence testing was conducted in the U.S. (or the ANDA qualifies for a waiver of bioequivalence testing);
2. The finished dosage form manufacturer is located in the U.S., and 
3. The API supplier is located in the U.S..

Benefits: Qualifying submissions are eligible to receive priority review under the FDA’s existing framework for submitting priority review requests (MAPP 5240.3 Rev. 6), which may include shorter goal dates or expedited processing. Importantly, the pilot program is additive to, and is not a replacement for, the FDA’s established prioritization policies. 

Application: Submitters must request priority review at the time of filing, referencing the pilot and providing supporting documentation.