The FDA Opens Submissions for PreCheck
What the new program means for U.S. drug manufacturing.
The FDA has formally opened submissions for its PreCheck pilot program, a new initiative to accelerate the development of pharmaceutical manufacturing facilities in the United States.
Announced last August and now entering its operational phase, the idea of PreCheck is to strengthen domestic drug supply chains by giving manufacturers earlier, more structured regulatory engagement while facilities are still being built—well before a specific drug application is submitted.
It’s a notable shift in how the agency approaches manufacturing readiness, particularly amid ongoing drug shortages, geopolitical supply risks, and sustained political pressure to onshore pharmaceutical production.
Here’s a quick breakdown of what the FDA has announced, how the program is structured, and what it may mean in practice for sponsors, manufacturers, and quality teams.
What is FDA PreCheck?
FDA PreCheck is a voluntary, pilot program that allows selected manufacturers to engage with the FDA earlier in the lifecycle of a new U.S. manufacturing facility (before the site is operational and before a specific product application is under review).
According to the FDA, the program is designed to:
Increase regulatory predictability during facility development.
Streamline certain aspects of facility assessment.
Reduce delays tied to manufacturing readiness at the time of application review.
Support faster availability of drugs for the U.S. market.
The agency has stated it will begin conducting PreCheck activities in 2026, starting with an initial cohort of selected facilities.
The launch of PreCheck comes amid more industry investment in U.S. manufacturing. Since early 2025, pharmaceutical companies have publicly pledged nearly $600 billion toward expanding their U.S. manufacturing footprint. These commitments followed direct political pressure to onshore production and reduce dependence on overseas supply chains.
FDA Commissioner Marty Makary framed PreCheck as part of a broader effort to reverse decades of offshoring and improve domestic manufacturing resilience.
How the FDA will select facilities
The FDA has outlined multiple selection criteria for the first PreCheck cohort.
Facilities will be evaluated based on:
The medicines that the site will manufacture.
The stage of facility development or construction.
The timeline for producing products for the U.S. market.
Innovation in facility development.
Alignment with national priorities.
Additional priority will be given to facilities producing “critical” medications for the U.S. market, though the agency has not publicly defined a single, fixed list of qualifying products.
This signals that PreCheck is not simply about speed—it’s explicitly tied to supply resilience and public health impact.
The two-phase structure of PreCheck
PreCheck is structured as a two-phase program, each with a distinct purpose.
Phase 1 is facility readiness. Selected manufacturers engage with the FDA before the facility is operational. Key elements include:
Pre-operational reviews
Early technical advice from FDA
Use of a facility-specific Drug Master File (DMF)
The goal at this first phase is to allow FDA reviewers to evaluate facility-specific elements such as design, systems, and controls in advance of a drug application. The idea here is to reduce the volume and complexity of manufacturing questions later in the application lifecycle.
Phase 2 is the application submission phase and builds directly on the work done in Phase 1. This phase includes:
Pre-submission meetings between FDA and the applicant
Inspections and application-related interactions
Focused resolution of facility-related issues
The FDA’s stated objective is to expedite assessment of manufacturing information during drug application review by addressing key readiness issues earlier.
Industry feedback and scope questions
The FDA’s final program design reflects feedback gathered during a public meeting held on September 30, 2025, as well as 75 public comments submitted through the Federal Register.
Major pharmaceutical companies including Novo Nordisk, AbbVie, Eli Lilly, Merck, Johnson & Johnson, and Amgen submitted comments supporting the program, while also urging the FDA to:
Expand eligibility to existing facilities under expansion
Include sites already under construction
Consider broader applicability beyond greenfield builds
Industry groups such as the Association for Accessible Medicines (AAM), U.S. Pharmacopeia, and the National Association of Manufacturers also voiced support. AAM in particular highlighted underutilized U.S. generic drug facilities that could be brought online faster than new construction (suggesting that regulatory acceleration alone may not be sufficient without parallel economic incentives).
What PreCheck does (and doesn’t) do
Based on the FDA’s published materials so far, PreCheck:
Does not replace inspections.
Does not waive cGMP requirements.
Does not guarantee application approval.
Does not eliminate the need for complete manufacturing data.
What it does offer is earlier regulatory alignment on facility design and readiness, potentially reducing late-stage surprises that delay approvals or trigger major remediation efforts.
For manufacturers, the practical value of it will depend on execution: how clearly expectations are communicated, how consistently feedback is applied, and how well early reviews translate into smoother application assessments.
If you’re considering participation, PreCheck reinforces a growing regulatory theme: manufacturing readiness is no longer something to address only at filing!
Programs like this will seem to reward earlier integration of Quality and Regulatory into facility design and more robust documentation of facility-specific systems and controls. For quality leaders, PreCheck may shift when and how compliance risks surface—but it does not reduce the need for rigorous internal readiness, data integrity, and inspection preparedness.
A few considerations and recommendations
Three things come to mind in light of PreCheck opening up:
