FDA PreCheck meeting weighs how more clarity may help de-risk US manufacturing investments

Industry participants overwhelmingly supported the initiative, but also called for greater clarity on its scope and eligibility requirements—particularly whether it applies to existing facilities, expansions, technology transfers, and/or specific manufacturing functions such as packaging. Companies also sought guidance on how the program will accommodate different product types, including biologics, generics, and combination products. Concerns were raised about integration of FDA PreCheck with existing regulatory pathways, programs, and tools, the need for defined criteria for prioritization, and the risk of regulatory overlap or unintended delays. Stakeholders emphasized the importance of meaningful incentives to promote domestic manufacturing—such as inspection waivers, simplified CMC submissions, and accelerated timelines—especially for small and generic manufacturers with lower return on investment for onshoring. Industry urged FDA to leverage prior facility approvals to reduce review submission burdens for replicated (“copy-paste”) manufacturing lines, which are identical to previously FDA-approved manufacturing lines, using the same equipment, processes, and controls.

FDA’s next steps in refining the program’s operational framework will be critical as the agency considers comments on the public docket, which is open until October 30, 2025. We also separately discuss below FDA’s newly-announced pilot program for priority review of abbreviated new drug applications (ANDAs), as one additional agency effort to boost investment in U.S. drug manufacturing.

Overview of the FDA PreCheck program

The FDA’s PreCheck Program is a two-phase initiative aimed at accelerating the development and approval of new high-priority pharmaceutical manufacturing facilities in the U.S. Phase 1, the “Facility Readiness Phase,” focuses on providing technical advice during facility design, construction, and qualification, allowing manufacturers to identify and resolve potential issues well before final inspections. At the public meeting, FDA described pre-application “proactive engagement before facilities become operational” as a “core feature” of PreCheck. Phase 2, the “Application Submission Phase,” enhances coordination between FDA and manufacturers during the review of chemistry, manufacturing, and controls (CMC) data. Early awareness of facility details may enable FDA to accelerate quality assessments and inspections, focusing on product-specific considerations rather than basic facility understanding. However, FDA emphasizes that only CMC assessments are expedited, while other review aspects (e.g., clinical data) will continue to follow standard timelines.

Key areas where industry seeks FDA clarification

At the meeting, industry participants highlighted several practical and procedural questions critical to the successful implementation of the PreCheck Program:

• Scope of the program: Stakeholders sought clarity on whether PreCheck would apply solely to entirely new facilities, or would also extend to existing sites, including expansions, addition of new product lines, and technology transfers. They also questioned whether parts of manufacturing such as packaging would be included in the program. There was particular interest in how contract development and manufacturing organizations (CDMOs) would be integrated, and whether the program would encompass technology upgrades or “copy-paste” facilities with identical lines.
• Program criteria and eligibility: Industry participants sought clearer definitions for qualifying facilities, including how FDA will prioritize applications, define “high priority” manufacturing, and address product types such as combination products, biologics, generics, and drugs addressing unmet medical needs. They emphasized the economic challenges faced by generic manufacturers and small companies, who face lower returns on investment for their U.S. manufacturing expenditures compared to the brand drug manufacturer counterparts, underscoring the need for meaningful incentives.
• Transparency and program flexibility: Industry urged FDA to publicly share program metrics, clarify eligibility and prioritization criteria, provide guidance or FAQs, and maintain ongoing dialogue through regular public meetings. There was a call to design the program with flexibility to accommodate evolving manufacturing technologies and modalities. Additionally, stakeholders emphasized that FDA needs to clarify how the PreCheck Program will work alongside existing guidance, regulatory tools (e.g., alternative tools), and FDA programs, including designations, the Emerging Technology Program (ETP), and the Advanced Manufacturing Technologies Designation Program, to ensure consistency and avoid overlapping efforts. For more on these existing programs, see our analysis of FDA’s Platform Technology Designation Program online here, and of the Advanced Manufacturing Technologies Designation Program online here.
• Early and ongoing FDA engagement: A dominant theme was the need for early, consistent, binding and actionable communication with a designated FDA liaison throughout the facility development lifecycle—from design through inspection and application submission. Industry applauded the proposal to leverage Type V Drug Master Files (DMFs) as a foundational tool, noting that developing DMFs would facilitate ongoing dialogue, and feedback. Companies asked how feedback from the early Facility Readiness Phase would be carried through to the later Application Submission Phase, to ensure consistency and avoid regulatory surprises.

Inspection timing and flexibility: Many participants voiced concerns about the current timing of PAIs, often late in the review cycle, which complicates addressing manufacturing issues close to product launch. Stakeholders urged decoupling GMP inspections from product application reviews to streamline processes, reduce bottlenecks, and allow risk-based waivers for facilities with well-established quality systems or “copy-paste” lines in accordance with FDA guidance on alternative tools. There was concern that information shared with FDA under the PreCheck program —particularly during design and construction—could later trigger FDA enforcement activities such as targeted inspections, if PreCheck discussions raised potential future GMP compliance GMP issues. FDA was encouraged to provide assurances that the program would not increase regulatory risk. Stakeholders raised concerns about ensuring PreCheck does not detract from or delay other critical FDA regulatory programs, including PDUFA timelines.

Industry-proposed incentives to strengthen PreCheck

Industry stakeholders broadly support the PreCheck program but emphasize the need for clear incentives to boost its adoption and effectiveness. Key proposals include:

• Pre-Approval Inspection (PAI) waivers or deferrals: Companies advocated that facilities with strong compliance records and robust DMFs especially Type 5 DMFs, should be eligible to skip or defer PAIs, reducing uncertainty and accelerating timelines. This would be especially beneficial for “copy-paste” or identical manufacturing lines, where risk-based flexibility could apply.
• Accelerated application review: There is interest in FDA offering priority or streamlined reviews for applications referencing PreCheck-approved facilities, helping speed approvals, particularly for new product lines, technology transfers, or expansions.
• Simplified application content: Stakeholders suggested reducing Chemistry, Manufacturing, and Controls (CMC) data requirements where facilities have already undergone extensive PreCheck review, allowing for more efficient application submissions.
• Cross-agency coordination and resource allocation: Participants recommended enhanced coordination between FDA and other government agencies (e.g., Customs and Border Protection, State Department) to address logistical challenges such as importing specialized equipment and workforce mobility.

Additional Industry Recommendations

Beyond incentives, industry participants identified several operational and strategic considerations to ensure the program’s long-term success and integration within the broader regulatory ecosystem:

• Consistency and continuity in FDA review teams: Industry emphasized the value of dedicated FDA teams engaged throughout the facility’s PreCheck participation to avoid conflicting advice and to build institutional knowledge. This continuity was described as vital for aligning inspection outcomes and application reviews.
• Use of third-party certification: Some support was raised for leveraging trusted third-party assessors to validate facility readiness, reducing FDA’s inspection burden while maintaining oversight. Some stakeholders proposed that this could be particularly useful for Contract Development and Manufacturing Organizations (CDMOs).

Our perspective on the PreCheck program

While it remains to be seen whether the PreCheck program will significantly alter the communication between FDA and industry regarding manufacturing facilities, the program may be a positive step toward de-risking U.S. manufacturing investments, if PreCheck lives up to its promise. As FDA frequently issues Complete Response Letters (CRLs) rejecting manufacturing sites over quality concerns, it is possible that early engagement with FDA through the PreCheck program can lead to more predictable outcomes and help companies better align their facility development with regulatory expectations.

That said, several factors will influence the adoption of the program and its success in promoting domestic manufacturing. FDA regulatory requirements are only one of many factors informing those decisions about where to locate manufacturing operation; other criteria including cost, supply chain logistics and workforce availability are also important considerations. Additional factors like tariff policy and other nations’ policies and incentives may also influence decisions about where to locate manufacturing operations. Structured communication with FDA at earlier stages of manufacturing development can help spur greater predictability and reduce barriers.

It also remains to be seen whether FDA will adjust the PreCheck program to reflect the feedback it received at the public meeting and through the open docket. FDA is currently operating under significant resource constraints, so proposals that would substantially expand FDA’s obligations by expanding the scope or eligibility criteria may be challenging to implement without Congressional appropriations or reallocation of current staff. In addition, the current government shutdown creates additional uncertainty regarding development and implementation of new policy initiatives. Furthermore, FDA remains bound by statutory requirements, including the obligation to evaluate a facility’s suitability in the context of a specific drug application. While early engagement is helpful, FDA is unlikely to be able to support a full decoupling of facility review from product-specific assessments under current law. In general, we expect that FDA will be most responsive to proposals clearly tied to the Trump administration’s broader efforts to promote domestic production, especially those that demonstrate a tangible commitment to building or expanding U.S.-based manufacturing capacity.

ANDA manufacturing prioritization pilot

On October 3, FDA separately announced a new pilot program for the review of abbreviated new drug applications (ANDAs), which the agency said “aims to spur and reward investment in U.S. drug manufacturing and research and development and strengthen the domestic pharmaceutical supply chain by providing faster reviews for generic companies who test and manufacture their products in the U.S.” Under this pilot, ANDA applicants who conduct any required bioequivalence testing in the U.S. – and whose products are made in the U.S. using exclusively domestic sources for APIs – are eligible for FDA priority review.

This brief program announcement provides little information about the ANDA pilot program, but instead references the PreCheck public meeting as a similar FDA effort. It encourages sponsors to follow existing procedures to prioritize an ANDA, while also “referenc[ing] this pilot program as the basis for prioritization.”

Next steps

As the PreCheck public meeting comment period remains open through October 30, 2025, companies considering U.S. expansion should evaluate whether PreCheck can support their regulatory strategy—and where there may be opportunities to shape the program further. Our team has deep experience advising companies on efforts to onshore manufacturing and can help evaluate when and how PreCheck might fit into a broader reshoring strategy. For example, online here we have provided a checklist of considerations for companies planning to build or expand U.S. pharmaceutical facilities, which can help companies take advantage of Trump’s Executive Order aimed at promoting American-made prescription drugs.

If you have questions about the PreCheck Program or would like assistance with preparing comments or planning for facility development, please contact the authors of this publication or your regular Hogan Lovells contact.

Authored by Elizabeth Jungman, David Horowitz, Sally Gu, and Ashley Grey