FDA Launches Manufacturing PreCheck Pilot Program To Boost U.S. Drug Production

FDA recently launched aManufacturing PreCheck Pilot Program("Pilot Program" or "PreCheck") designed to strengthen the domestic pharmaceutical and biologics supply chain by reducing regulatory barriers and increasing predictability in the drug manufacturing inspection and approval process. FDA firstunveiledits plans for the PreCheck program last summer, and is now deploying it within the context of a 2025Executive Orderpromoting domestic production of critical medicines. As such, the Pilot Program aims to accelerate the establishment of high-priority new manufacturing facilities in the U.S.

The Pilot Program uses a two-phase approach to engage manufacturers early:

• Phase 1: Prior to facility operation and product submission, FDA provides early technical advice during facility design and construction through pre-operational reviews and use of a facility-specific Drug Master File (DMF).
  
• Phase 2: Building on Phase 1, FDA and the manufacturer hold pre-submission meetings and plan for coordinated inspections, aiming to resolve any remaining issues and streamline the Chemistry, Manufacturing, and Controls (CMC) review for the facility's first product application.

Eligibility Requirements

The Pilot Program is open only to new manufacturing sites in the United States (U.S.). The facility must be a newly constructed or planned site that has broken ground (or will by the application deadline) for human drugs or biologics production. The facility must also have capacity to contribute significantly to U.S. drug supply needs, e.g., by producing high volumes of critical medicines or fully covering a niche need, such as a rare disease.

Only seven applicants will be accepted into the Pilot Program initially. FDA intends to use the real-world data collected during the Pilot Program to refine the PreCheck process and "enhance the program." FDA will also consider whether a facility can be used as a model for future manufacturing facilities the company plans to develop. That said, it is unclear whether FDA will extend the program to include additional manufacturers.

Benefits of Participation

Manufacturers accepted into the PreCheck Pilot can expect several key benefits, including:

• Close collaboration with FDA during critical early stages of facility development.
  
• Ongoing, structured dialogue with FDA regulators throughout the facility evaluation lifecycle, including the construction and inspection process.
  
• Early FDA feedback in Phase 1 to identify compliance issues prior to the formal application review.
  Beyond these regulatory benefits, participating in PreCheck also signals a company's commitment to quality and supply chain reliability, which can enhance its reputation with FDA and stakeholders.

Practical Considerations for Manufacturers

PreCheck participation comes with limitations and considerations for manufacturers to weigh:

• Participation is voluntary and does not guarantee any expedited approval or positive inspection outcome for a future product. Companies must still pass all usual reviews and inspections but will likely benefit from early engagement with FDA regardless.
  
• Engaging in PreCheck requires a significant commitment of time and resources. Firms should expect regular meetings and information exchanges with FDA throughout the project, and possibly, site visits by FDA officials during the build-out phase.
  
• FDA's submission form includes affirmative commitments, such as agreeing to share facility information through a DMF, submitting the planned drug application, and continuing manufacturing at the site for three years.
  
• Any information submitted as part of a DMF remains proprietary and confidential.

Additional Considerations for Prospective Applicants

Manufacturers considering PreCheck should review FDA's selection priorities and evaluate how well their project fits key criteria. Facilities stand the best chance if they are using domestically sourced ingredients, producing therapies for critical needs or shortage areas, employing innovative manufacturing technologies, and demonstrating an accelerated path to operation.

Further, as part of the PreCheck Pilot, FDA will use a Type V DMF as the primary mechanism for reviewing facility-specific information—such as site design, quality systems, utilities, and validation strategies—independent of any single drug application. A Type V DMF allows FDA to assess manufacturing readiness earlier in the lifecycle and to carry those findings forward into later NDA, ANDA, or BLA reviews and inspections, without compromising a manufacturer's proprietary data. Accordingly, manufacturers should also consider preparing the groundwork for the Type V DMF, i.e., compiling documentation on their site's layout, utilities, quality systems, and operational protocols.

Manufacturers should also plan for potential FDA visits during construction, and accordingly, maintain detailed records of construction quality and validation activities to show inspectors.

Key Takeaways

Overall, FDA's Manufacturing PreCheck Pilot Program offers an innovative avenue for early regulatory engagement in facility development, representing a significant opportunity for eligible pharmaceutical manufacturers. Companies that prepare thoroughly and align with the Pilot Program's goals can potentially reduce regulatory uncertainties and expedite time-to-market for critical medicines—all while contributing to a more resilient U.S. drug supply chain.

Applicants must submit an initial request by March 1, 2026. The application requires details on the facility's focus, anticipated products/therapeutic areas, development stage, production capacity, and timeline for completion. FDA will evaluate submissions and select a limited number of finalists by April 1, 2026. The agency will then ask those finalists for additional information. Final selections are expected by June 30, 2026, with Phase 1 PreCheck engagements for the chosen cohort beginning shortly after.

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