Key Takeaways:
- Launch Date: October 6, 2025
- Objective: Accelerate review timelines for Abbreviated New Drug Applications (ANDAs) for generics manufactured entirely in the U.S.
- Eligibility: Applicants must conduct bioequivalence testing and source all APIs and dosage manufacturing domestically.
- Strategic Goal: Reduce reliance on foreign drug manufacturing, currently, 91% of APIs are imported, and build a secure, affordable national drug supply.
Program Overview
The U.S. Food and Drug Administration (FDA) has unveiled a new pilot program designed to encourage domestic research, development, and manufacturing of generic drugs. Announced on October 6, 2025, the initiative offers faster review timelines for Abbreviated New Drug Applications (ANDAs) that meet stringent U.S.-based production criteria.
To qualify, companies must demonstrate that bioequivalence testing, active pharmaceutical ingredient (API) sourcing, and final dosage manufacturing occur entirely within the United States. Although the FDA has not specified the exact reduction in review time, the program seeks to improve upon the typical 10-month review window, delivering generics to market more quickly.
Strengthening Domestic Capabilities
This move is part of the FDA’s broader strategy to address vulnerabilities stemming from heavy dependence on foreign manufacturing. Current data from 2025 indicates that only 9% of API manufacturers operate domestically, compared to 22% in China and 44% in India. By incentivizing local production, the FDA aims to mitigate national security risks and ensure consistent patient access to critical medications.
“Overreliance on foreign drug manufacturing and testing creates risks both to national security and patient access,” said George Tidmarsh, Director of the FDA’s Center for Drug Evaluation and Research. He emphasized that the program will promote a resilient and affordable drug supply, safeguarding both industry competitiveness and public health.
Part of a Broader Modernization Agenda
The initiative adds to a growing list of FDA programs focused on accelerating drug development and approval pathways. In July 2025, the agency introduced the Commissioner’s National Priority Voucher Program, reducing certain drug reviews from 10–12 months to 1–2 months. In September, draft guidance for cell and gene therapy companies proposed streamlined clinical trials and expanded use of real-world data in post-approval monitoring.
Together, these measures reflect the FDA’s ongoing commitment to modernize U.S. manufacturing infrastructure, reduce supply chain vulnerabilities, and ensure faster access to affordable medicines produced on home soil.
