FDA PreCheck Pilot Program

FDA PreCheck Pilot Program is sponsored by U.S. Food and Drug Administration (FDA). This opportunity supports mission-aligned projects and measurable outcomes.

FDA Launches Manufacturing Pre-Check Pilot Program | Covington & Burling LLP FDA Launches Manufacturing Pre-Check Pilot Program The U.S. Food and Drug Administration (FDA) has launched the Manufacturing Pre-Check (PreCheck) Pilot Program, an initiative intended to promote domestic pharmaceutical manufacturing by enabling earlier and more predictable FDA engagement in reviewing new U.S.-based drug manufacturing facilities.

The program is designed to facilitate new facility development and streamline FDA’s assessment of manufacturing sites before they are tied to a specific drug application, without altering existing statutory or regulatory standards. The application window for the pilot closes on March 1, 2026, making near-term evaluation and submission decisions critical for companies interested in participating.

FDA has limited the initial pilot to new manufacturing facilities, declining to extend the program—at least at this stage—to product transfers, facility expansions, or modernization of existing sites, notwithstanding significant industry feedback urging a broader scope.

The pilot reflects FDA’s broader effort to shift meaningful regulatory engagement earlier in the lifecycle of new manufacturing facilities, particularly those supporting supply-chain resilience and the production of critical medicines. Program Scope, Eligibility, and Selection Participation in the PreCheck pilot will be limited to an initial cohort of new pharmaceutical manufacturing facilities located in the United States.

FDA has indicated that the program is directed at facilities in the design, construction, or pre-operational stages, rather than existing or fully operational sites. Participating facilities must intend to manufacture FDA-regulated pharmaceutical products and be prepared to engage in early and ongoing technical discussions with FDA during facility development.

By focusing the PreCheck pilot on new manufacturing facilities, FDA declined to adopt a central recommendation raised in industry feedback during the program’s development—namely, that the program also be used to support product transfers, facility expansions, or modernization of existing facilities.

Numerous stakeholders urged FDA to broaden the program’s scope to include facility expansions and technology transfers as a more immediate means of increasing domestic manufacturing capacity and addressing supply-chain vulnerabilities. As the PreCheck pilot has not been scoped accordingly, this may limit its effectiveness in addressing key weaknesses in the U.S. supply chain for pharmaceuticals.

FDA has stated that participation will be competitive and that facilities will be selected based on overall alignment with national priorities, evaluated across multiple factors. These include the products to be manufactured, the stage of facility development, the anticipated timeline for producing pharmaceutical products for the U.S. market, and innovation in facility design or development.

FDA has also indicated that it will give additional priority consideration to facilities that plan to manufacture critical medications for the U.S. market. The agency has not published a scoring rubric or explained how these factors will be weighted. FDA has emphasized that participation in PreCheck does not alter regulatory requirements, guarantee inspection outcomes, or confer expedited or preferential product approval.

Program Structure and Submission Process FDA has described PreCheck as consisting of two phases. In Phase 1 (Facility Readiness Phase), selected facilities will engage with FDA for early technical advice and pre-operational review, including review of facility-specific information submitted in advance of any product application.

FDA has highlighted the use of a facility-specific Drug Master File (DMF) as a mechanism for sharing information related to facility design, manufacturing operations, and quality systems at this stage.

In Phase 2 (Application Submission Phase), FDA and participating facilities will build on that engagement through pre-submission meetings and inspections tied to a specific drug application, with the goal of enabling a more efficient assessment of manufacturing information during application review.

FDA has clarified that PreCheck is not tied to a specific NDA, BLA, or ANDA at the outset and does not modify substantive regulatory standards. FDA has indicated that the application window closes on March 1, 2026. FDA expects to identify finalists and request any additional information by April 1, 2026, with a deadline of May 1, 2026, for finalists to submit additional materials.

FDA has stated that it intends to select the initial pilot cohort by June 30, 2026, and to begin conducting PreCheck activities later in 2026.

Key Questions and Ambiguities in the PreCheck Submission Form The online PreCheck submission form operates primarily as a screening and commitment-testing tool, signaling that FDA is assessing whether applicants are operationally serious, sufficiently advanced, and aligned with domestic manufacturing priorities.

Applicants are required to describe manufacturing focus, anticipated products and therapeutic areas, development stages, and quantified production capacity, indicating a focus on operational credibility rather than aspirational plans. The form also emphasizes drug-shortage and essential-medicine relevance, although it does not clarify how a lack of relevance will be treated in selection decisions.

Questions regarding facility development status and timelines suggest that the program is intended for projects already moving forward, but FDA does not define acceptable timelines or minimum thresholds. The form similarly treats innovation—such as modular construction, automation, and continuous manufacturing—as a selection signal, without clarifying whether more conventional facilities are disfavored.

Finally, the form requires a series of affirmative commitments, including compliance and national-security representations; agreement to pre-operational engagement; willingness to share information via a Type V DMF; commitments to submit NDAs, ANDAs, or BLAs; and a commitment to manufacture products at the facility for at least three years after FDA approval.

The form does not explain the consequences of failing to meet these commitments or how partial compliance would be addressed. The application window closes on March 1, 2026. PreCheck provides a mechanism for earlier FDA engagement, not regulatory relief or expedited approval.

The pilot is focused on new U.S. manufacturing capacity, particularly facilities supporting critical medicines. FDA has chosen not to extend the pilot, at least initially, to product transfers or expansions of existing facilities, notwithstanding significant industry feedback urging a broader scope. Selection will be competitive and priority-driven, with an emphasis on readiness, innovation, and supply-chain relevance.

Covington is closely monitoring developments related to the PreCheck Pilot Program. We assist clients in assessing eligibility, shaping application strategies and timelines, and preparing the regulatory and technical materials necessary for submission. If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.

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