On Feb. 1, 2026, the FDA officially launched its Manufacturing PreCheck Pilot Program, which is intended to de-risk and accelerate the establishment of U.S. pharmaceutical manufacturing facilities by increasing regulatory predictability, facilitating construction and readiness, and streamlining certain quality assessments in advance of a specific product application. The FDA is accepting proposals on a rolling basis and will select eligible participants based on factors aimed at national priorities. Sponsors should assess whether their new facility qualifies for the PreCheck initiative and engage with the FDA as early as feasible to take advantage of this new initiative.
Sponsors who wish to participate must submit their request for inclusion in the PreCheck Pilot by March 1, 2026, and the FDA is already accepting applications. The FDA will select a group of finalists for the program by April 1, 2026. They will be asked to submit additional information to be considered for the initial cohort of PreCheck Pilot participants. The FDA plans to announce the final selection by June 30, 2026.
What Is FDA’s PreCheck Pilot Program?
The PreCheck Pilot Program is a voluntary, two-phase initiative. The FDA will choose an initial cohort of seven participants, with the goal of refining the program so that it can be applied more broadly in the future.
- Phase 1 is the “Facility Readiness Phase,” in which the agency provides qualifying programs with early, pre-operational engagement with the FDA on facility design, construction, qualification and quality system readiness. The FDA engagement is focused on developing and critiquing facility-specific aspects of applications, such as a Drug Master File (DMF), that can support subsequent product applications.
- Phase 2, the “Application Submission Phase,” builds on Phase 1 by providing pre-submission meetings dedicated to resolving manufacturing-related issues, enabling earlier assessment of quality elements and inspection planning within the review cycle for applications referencing new U.S. facilities. The FDA has emphasized that PreCheck may expedite manufacturing-related assessments and pre-approval inspection readiness.
Eligibility Requirements for PreCheck Pilot Program
The PreCheck Pilot program is open to manufacturers establishing new U.S. manufacturing facilities for human drugs and biologics that will produce sufficient quantities to satisfy the intended need/market. The facility must not be an existing facility or an extension of one. The facility should be pre-operational, or the participant must have broken ground or have plans to break ground prior to May 1, 2026. Participants must commit to submitting a new drug application, an abbreviated new drug application (ANDA), a biologics license application, an application supplement for drug substance (DS), finished dosage forms (FDFs)/drug product, or a Type II DMF for small molecule active pharmaceutical ingredients (APIs). Participants also must commit in advance that they will be “actively manufacturing” products in that same facility for at least three years after the FDA’s approval of the products manufactured during the PreCheck Pilot.
In selecting the initial cohort of seven participants, FDA plans to prioritize:
- participants with past pharmaceutical manufacturing experience;
- facilities that manufacture US FDFs or drug products using U.S. APIs or DSs, or those that manufacture U.S. API/DS using U.S. key starting materials;
- facilities that will develop products for drug shortages, critical medicines or key supply chain vulnerabilities; large volume parenteral products; or other therapeutically essential medications identified on the FDA shortage lists or critical medicine designations;
- facilities where sponsors are willing to provide extensive facility inspection information and participate in the Pre-Operational Review activities; and
- facilities that can achieve operational status on an expedited timeline.
Additionally, the FDA will evaluate facilities that employ novel approaches to design, construction or implementation, such as modular or prefabricated construction, advanced automation or digital integration, which could accelerate development timelines or enhance manufacturing efficiency. Notably, the FDA will give special consideration to facilities designed as replicable templates that could serve as models for rapid large-scale construction or for innovative approaches with broader applicability within the domestic pharmaceutical manufacturing sector. Depending on the technologies involved, engagement with the FDA’s Emerging Technology Program or the CBER Advanced Technologies Team may also be appropriate. The FDA’s announcement clarifies that the initiative applies equally to large and small manufacturers as well as contract development and manufacturing organizations “that have agreements in place with experienced sponsors and a documented willingness to share information with their proposed partner sponsors about the proposed facility.”
For each company participant, the FDA plans to include only one facility in the PreCheck initiative. For multi-product facilities, the agency has indicated it may limit the quantity of product-specific submissions from a single participant.
Potential Impact
By engaging with the agency during design and construction and documenting facility capabilities, sponsors and manufacturers included in the PreCheck Pilot Program can obtain earlier FDA feedback on quality systems and operational readiness, potentially reducing late-cycle surprises and manufacturing-related Complete Response Letter risks. Early awareness can allow the FDA to tailor inspections and quality assessments to product-specific issues, potentially smoothing the path during application review.
PreCheck sits alongside other recent FDA efforts to bolster domestic capacity, including a pilot to prioritize ANDAs for products tested and manufactured in the U.S., signaling a multi-pronged approach to incentivize U.S. manufacturing. The FDA has invited continued public input and considered comments submitted to the public docket last year in connection with its public meeting in September 2025 regarding onshoring manufacturing.
However, there are unresolved details that may impact the scope and success of the PreCheck Pilot program. For example, the FDA noted that approval decisions ultimately depend on application-specific data and inspection results, and that PreCheck cannot fully substitute for product-linked pre-approval or pre-license inspections. That approach leaves potential participants that cannot time submissions aligned with the agency’s schedule out of luck for this initial cohort.
Additionally, the FDA previously solicited comments on participants’ willingness to share potentially sensitive facility information at such early stages. The industry flagged potential risks if early consultations trigger future enforcement scrutiny and requested assurances that PreCheck participation will not increase regulatory exposure.
The PreCheck Pilot Program announcement does not explicitly address these concerns, underscoring the need for clear guardrails as the program develops. Resource constraints may similarly limit how broadly and quickly the FDA can scale the PreCheck Pilot program without additional appropriations or staffing.
Further, as currently conceived, the PreCheck program is limited to pharmaceutical products. Query whether PreCheck may eventually be expanded to include medical device manufacturing or food processing facilities under similar concepts to encourage onshoring of such facilities.
Key Takeaways for Regulated Industry Seeking Inclusion
- Submit proposals for eligible facilities as soon as feasible. With the program now open and accepting applications on a rolling basis, and initial selection of finalists occurring on April 1, 2026, firms planning new U.S. facilities should consider submitting a proposal, aligning project details with the FDA’s stated selection factors — especially those related to national priorities — as soon as feasible.
- Propose concrete inspection plans. Those submitting requests for inclusion in the PreCheck initiative must map out facility plans and establish timelines and milestones. Those without concrete plans to break ground prior to May 1, 2026, risk being ineligible for the initial PreCheck Pilot program cohort.
- Anticipate limits and preserve flexibility. Recognize that PreCheck does not eliminate product-specific inspection and approval requirements, and plan for resource or statutory constraints as the FDA implements the pilot. Sponsors should consider whether the expedited timelines for facility readiness and inspections could divert resources and time needed to ensure that the product application timelines can be met. The FDA explicitly states that inclusion in the program does not alter statutory and regulatory requirements, and participants are not guaranteed positive inspection outcomes or expedited approvals. Sponsors therefore must set realistic expectations for application and inspection readiness and carefully consider whether inclusion in the PreCheck Pilot will impact the time to market for products in development.
Interested applicants should submit proposals through the FDA’s submission page. The FDA plans to notify those selected as finalists by Apr. 1, 2026. Applicants should be prepared to provide more detailed plans and additional information on the facility upon receiving email notification that they have been selected as finalists, and they will have until May 1, 2026, to submit the requested information. Accordingly, applicants should begin compiling more detailed information shortly after submitting the initial proposal to ensure timely responses to the FDA’s follow-up requests.
McGuireWoods’ Life Sciences Industry Team continues to monitor developments related to the FDA’s expedited review and development programs for drug and biologics manufacturing. For questions about related topics, contact the authors or a member of the team.