FDA Launches PreCheck Pilot to Accelerate Domestic Drug Manufacturing Reviews
The U.S. Food and Drug Administration has selected seven companies for its PreCheck pilot program, an initiative designed to expedite the review of new domestic pharmaceutical manufacturing facilities.
The Selected Companies:
- Eli Lilly
- Regeneron
- Amneal
- Cellares
- Fujifilm Biotechnologies
- Kriya Therapeutics
- Kyowa Kirin
The program allows FDA regulators to begin reviewing facilities while they are still under construction, potentially saving companies up to 14 months.
To qualify for the pilot, companies were required to build a new facility capable of producing drugs that address a market supply gap or improve access to therapies for unmet medical needs. Only drugs relying on that specific facility are covered under the program.
Producing more drugs domestically has been a priority for the Trump administration. The majority of the selected companies plan to manufacture biologic drugs or genetic medicines.