FDA Launches PreCheck Pilot Program, Selects Seven Drugmakers Including Eli Lilly and Regeneron to Accelerate Manufacturing Approvals
N.R. Finch
The FDA has picked Eli Lilly, Regeneron, and five other drugmakers for its PreCheck pilot, letting regulators review new factories while they are still being built — a move that could shave up to 14 months off approval timelines and marks a concrete step in the push to bring drug manufacturing back to the U.S.
What exactly is PreCheck?
PreCheck — the FDA's new manufacturing-approval pilot — has a simple premise: start the regulatory review while the factory is still under construction, instead of waiting until it is finished.
This means → the old sequence of "build the plant → file the application → wait for approval" gets compressed from serial into parallel.
The program has two phases: facility-readiness review, where FDA provides technical guidance before a site opens, and application submission, where companies get faster inspections and more direct feedback.
In plain terms = instead of handing in a finished assignment and waiting for a grade, the teacher watches over your shoulder as you write.
Which seven companies were selected, and what will they make?
Eli Lilly: a plant in Lebanon, Indiana, producing the key active ingredients for GLP-1 oral and injectable drugs — the hottest category in the weight-loss / diabetes pipeline.
Regeneron: a $2 billion new facility in Saratoga Springs, New York, announced last fall, set to produce biologic drug substance, sterile injectables, and protein therapeutics.
Fujifilm Biotechnologies: a site in Holly Springs, North Carolina, already operational and manufacturing monoclonal antibodies — precision proteins that target specific disease sites — for Regeneron and Johnson & Johnson, with full-scale production planned for 2027–2028.
What about the other four?
Amneal Pharmaceuticals: a New York facility producing small-molecule sterile liquid products for pain, respiratory, and ophthalmic conditions.
Cellares: a New Jersey site manufacturing cell and gene therapies — treatments that re-engineer a patient's own cells and infuse them back — for cancer and blood disorders.
Kriya Therapeutics: a North Carolina facility producing AAV gene therapies — using modified viral carriers to deliver therapeutic genes into the body — for chronic diseases.
Kyowa Kirin: a North Carolina site producing biologics for rare diseases.
Why are most of the selected companies making biologics?
Most of the seven plan to produce biologics or gene therapies, not conventional oral pills.
This means → biologic manufacturing is far more complex than chemical-drug production — it demands strict temperature control, sterile environments, and precise cell-culture conditions. Approval timelines are inherently longer, so PreCheck's time savings matter most here.
There is also a hard eligibility bar: each new facility must produce drugs that fill a market supply gap or address an unmet medical need.
What is the policy signal behind this?
Bringing drug manufacturing back to U.S. soil is a stated priority of the Trump administration, and PreCheck is the concrete policy tool in that direction.
This reflects a broader shift — Washington is moving from "incentivize R&D" to "incentivize manufacturing repatriation," pushing drugmakers to build production lines at home, not just labs.
In plain terms = whether PreCheck can be replicated at scale and genuinely shorten industry-wide approval cycles is the key test of whether this policy actually delivers.
Content is for reference only, not financial advice.