Regulatory & Policy

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

Category: Regulatory Policy | Regulatory Body: FDA | Geography: United States | Instrument: Initiative launch

Edited by Robert McTiernan··4 min read
FDA launches PreCheck Pilot program to accelerate domestic drug manufacturing facility approvals

The FDA announced 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, 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.

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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

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