FDA launches PreCheck Pilot program to accelerate domestic drug manufacturing facility approvals

The FDA [announced ](https://www.fda.gov/news-events/press-announcements/fda-selects-seven-participants-precheck-pilot-program-advance-us-drug-manufacturing)on June 29, 2026, the selection of seven companies to participate in its PreCheck Pilot Program, a two-phase initiative designed to accelerate regulatory readiness for new domestic pharmaceutical manufacturing facilities. The program was formally launched on February 1, 2026, in response to [Executive Order 14293](https://www.presidency.ucsb.edu/documents/executive-order-14293-regulatory-relief-promote-domestic-production-critical-medicines), signed by President Trump in May 2025, which directed federal agencies to strengthen US drug manufacturing capacity. From a pool of more than 80 applicants, FDA selected participants using a structured scoring rubric that evaluated product type, facility development stage, anticipated market timeline, and manufacturing innovation. ## What it covers The PreCheck Pilot Program operates in two sequential phases. In Phase 1 (Facility Readiness), selected companies receive early technical guidance from FDA reviewers before the facility enters regulatory review, with FDA conducting assessments through a facility-specific Drug Master File submitted by the applicant. This pre-operational engagement is intended to surface and resolve potential compliance deficiencies before they can delay or derail a subsequent drug application. In Phase 2 (Application Submission), participants gain access to enhanced pre-submission meetings focused specifically on facility evaluation, enabling earlier inspection scheduling within the application review cycle. Eligibility required companies to commit to submitting an NDA, BLA, ANDA, or a supplement to one of those application types that relies on the new facility. The seven selected participants span a range of modalities and therapeutic areas: * **Amneal Pharmaceuticals** (Long Island, New York) — small molecule sterile liquid products for pain management, respiratory, and ophthalmic diseases * **Cellares Corp.** (Bridgewater, New Jersey) — cell-based gene therapy products for oncology and hematology * **Eli Lilly** (Lebanon, Indiana) — active pharmaceutical ingredients in support of existing and future medicines * **FUJIFILM Biotechnologies** (Holly Springs, North Carolina) — commercial-scale cell culture biomanufacturing * **Kriya Therapeutics, Inc.** (Durham, North Carolina) — AAV-based gene therapy products for chronic disease * **Kyowa Kirin, Inc.** (Sanford, North Carolina) — biotechnology drug substance for rare diseases * **Regeneron Pharmaceuticals** (Saratoga Springs, New York) — biotechnology drug substance, sterile injectables, and novel protein therapeutics ## Why it matters Manufacturing-related deficiencies are among the most common — and costly — causes of application delays and Complete Response Letters, making earlier FDA engagement at the facility level a meaningful risk-reduction tool for sponsors. By enabling FDA review of facility design and operational readiness before an NDA, BLA, or ANDA is filed, the PreCheck model shifts a significant portion of manufacturing compliance work upstream, potentially compressing post-submission review timelines. For companies building new US facilities — particularly in capital-intensive modalities like cell and gene therapy or large-molecule biologics — the program offers a structured pathway to inspection readiness that has not previously existed in a formalized form. The selection of participants across both established large-cap manufacturers and emerging biotechs signals that the program is designed to be broadly accessible, not limited to companies with existing FDA relationships. More broadly, the pilot reflects a policy environment in which domestic manufacturing investment is being actively incentivized through regulatory mechanism, not just trade or tax policy — a distinction that drug developers evaluating facility siting decisions should factor into their strategic planning. ## What to watch * **Pilot outcomes and program expansion:** FDA has indicated it will evaluate implementation and assess opportunities to inform future program development; whether PreCheck becomes a permanent, broadly available pathway will depend heavily on the operational experience generated by these seven participants over the coming years. * **Inspection and review cycle data:** The program's core value proposition rests on whether early FDA engagement demonstrably shortens facility inspection timelines and reduces manufacturing-related deficiencies at submission; sponsors and investors should watch for FDA to publish outcome metrics as the pilot matures. * **Scope of eligible modalities:** The current cohort skews toward complex, high-risk modalities — AAV gene therapies, cell therapies, and biologics drug substance — where manufacturing readiness has historically been a bottleneck; future cohort selection criteria may signal whether FDA intends to broaden eligibility to conventional small molecule manufacturing. * **Interaction with existing CMC pathways:** How PreCheck Phase 1 and Phase 2 engagements will interface with existing Chemistry, Manufacturing, and Controls guidance, Type B meeting procedures, and pre-approval inspection scheduling remains to be clarified — details that will determine the program's practical utility for regulatory affairs teams. *** *Source: US Food and Drug Administration press announcement, June 29, 2026.* [https://www.fda.gov/news-events/press-announcements/fda-selects-seven-participants-precheck-pilot-program-advance-us-drug-manufacturing](https://www.fda.gov/news-events/press-announcements/fda-selects-seven-participants-precheck-pilot-program-advance-us-drug-manufacturing) *** This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: [https://allsci.com/news/](https://allsci.com/news/) --- Spot something wrong? 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