FDA selects Lilly, Regeneron for fast-track facility reviews

Eli Lilly and Regeneron are among the first seven companies selected for an FDA pilot program designed to accelerate reviews of new domestic pharmaceutical manufacturing facilities. The initiative, called PreCheck, lets regulators begin evaluating sites while they’re still under construction, potentially cutting up to 14 months off the usual timeline.

FDA spokesperson Benjamin Nichols confirmed the selection.

Producing more drugs inside the U.S. has been a priority for the Trump administration. The selected companies range from the most valuable healthcare firm in the world to small biotechs developing gene therapies. The majority plan to make biologic drugs or genetic medicines, which involve more complex manufacturing.

How the PreCheck program works

The pilot has two parts. The first is facility readiness, where the agency provides technical guidance before the site opens. The second is application submission, where participants get hands-on feedback and can receive expedited inspections and facility evaluations.

To qualify, companies had to be building a new plant capable of making drugs that address a market supply gap or improve access to therapies for unmet medical needs. Only drugs that rely on that specific location are covered by the program.

Which facilities were selected

Amneal Pharmaceuticals – a New York plant making small molecule sterile liquid products for pain management, respiratory, and ophthalmic diseases, addressing recurring supply gaps in these areas.
Cellares – a New Jersey plant producing cell-based gene therapies for oncology and hematology.
Eli Lilly – its Lebanon, Indiana, plant that will manufacture the main ingredients of GLP-1 pills and shots.
Kriya Therapeutics – a North Carolina plant for adeno-associated virus-based gene therapies targeting chronic diseases.
Kyowa Kirin – a site in the same state for biologics treating rare diseases.
Regeneron – a $2 billion Saratoga Springs, New York, location that will produce biologic drug substance, sterile injectables, and protein therapeutics.

Company responses and expectations

Lilly said it’s evaluating how PreCheck and related regulatory improvements may affect the timeline for its Indiana location, and the company noted it will continue working closely with regulators to support its success. Regeneron CEO Leonard Schleifer said the firm has invested heavily in U.S. biologics manufacturing and pushed for more domestic production of medicines. “We’re pleased to see programs like the FDA’s PreCheck Pilot Program that encourage collaboration between innovators and regulators,” he said in a statement. Fujifilm’s new plant in that state opened last year and is already making monoclonal antibodies for customers Regeneron and Johnson & Johnson. It expects to produce for other customers as additional parts of the site come online in 2027 and 2028. Fujifilm said it anticipates an operational readiness review before the end of the year thanks to the expedited process, and that the program should allow its customers to explore faster approval pathways.

The agency has not disclosed how long the pilot will run or whether it will expand after the initial seven participants. But it estimates that catching manufacturing issues during construction, rather than after completion, could save companies more than a year in time-to-market for new drugs.