FDA Selects Seven Companies to Pilot PreCheck, Bringing Drug Manufacturing Review Earlier

Drug shortages are often seen in hospital wards and pharmacies, but their starting point is often much earlier: the design, validation, inspection, and application materials for a facility. A delay in any one link may leave a treatment stuck deep in the supply chain. On June 29, the U.S. Food and Drug Administration (FDA) announced that it had selected seven companies to participate in the PreCheck pilot program, in an effort to move regulatory interaction earlier, before new manufacturing facilities have formally entered production.

The selected companies include Amneal Pharmaceutical, Cellares, Eli Lilly, FUJIFILM Biotechnologies, Kriya Therapeutics, Kyowa Kirin, and Regeneron. These projects cover different manufacturing settings, including small-molecule sterile liquid formulations, cell-based gene therapies, AAV gene therapies, biotechnology drug substances, commercial-scale cell culture manufacturing, sterile injectables, and novel protein therapeutics.

The core of PreCheck is not to lower review standards, but to change the timing of review involvement. According to the FDA, the first phase focuses on “facility readiness,” allowing companies to submit information through site-specific Drug Master Files before a facility is operational and receive technical feedback. The second phase then connects with drug or biologics applications through facility-focused pre-submission meetings, bringing inspections and facility assessments into the review process earlier.

The pilot also has a clear industrial policy dimension. The FDA said PreCheck was launched in February 2026, against a backdrop that includes a May 2025 executive order and earlier public meetings on domestic manufacturing challenges. Official language emphasizes the resilience of the U.S. drug supply chain, domestic manufacturing capacity, and reliance on overseas production capacity. For the biotech industry, this also reflects that the manufacturing of advanced therapies and critical drugs is no longer only a matter of corporate operations, but part of national medical security.

The manufacturing types represented by the seven companies differ widely. Amneal’s facility in Long Island, New York, will manufacture sterile liquid products related to pain management, respiratory diseases, and ophthalmic diseases; Cellares’ facility in Bridgewater, New Jersey, will produce cell-based gene therapies for oncology and hematologic diseases; Eli Lilly’s facility in Lebanon, Indiana, will support drug substances needed for existing and future medicines. North Carolina has also become a key area, with FUJIFILM, Kriya, and Kyowa Kirin respectively laying out cell culture biomanufacturing, AAV gene therapy, and rare disease-related biotechnology drug substances.

For patients, the most direct promise of this kind of program is to reduce application delays caused by manufacturing issues and improve access to critical drugs. For regulators, the real test is how to provide sufficiently clear expectations early while avoiding companies interpreting the pilot as a fast pass. In particular, quality control for gene therapies, cell therapies, and protein drugs depends heavily on process consistency. If manufacturing facilities, analytical methods, or release standards are still changing, early communication can only reduce uncertainty; it cannot replace complete evidence.

Public information remains limited for now. The FDA has disclosed the list of selected companies, facility locations, and manufacturing scopes, and also said it received more than 80 requests to participate and evaluated them based on factors including product type, facility development stage, expected time to market, and manufacturing innovation. But the specific products, production capacity scale, extent of shortened review timelines, and pilot performance indicators for each company have not yet been fully disclosed. Whether PreCheck can become part of a future system will depend on whether it can expose manufacturing gaps earlier, and allow them to be corrected earlier, without diluting quality requirements.