Lexology October 8, 2025
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...
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