Key Takeaways:
- The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to reduce U.S. reliance on foreign pharmaceutical production and strengthen national supply chain security.
- The program features a two-phase approach: (1) a Facility Readiness Phase, which increases FDA-manufacturer communication during facility design and construction and encourages submission of comprehensive facility information via a Type V Drug Master File; and (2) an Application Submission Phase, which streamlines the Chemistry, Manufacturing and Controls (CMC) review process through pre-application meetings and early feedback.
- The FDA will hold a public meeting, "Onshoring Manufacturing of Drugs and Biological Products," on September 30, 2025, to present the PreCheck framework, gather stakeholder input and discuss challenges and opportunities related to onshoring drug and biologic manufacturing in the U.S.
Overview
On August 7, 2025, the U.S. Food and Drug Administration (FDA) announced the launch of the FDA PreCheck program, a new regulatory initiative designed to streamline and expedite the construction and approval of domestic pharmaceutical manufacturing facilities. This program is a direct response to Executive Order 14293, issued earlier this year, which directed the FDA to provide regulatory relief and promote the onshoring of critical drug production in the United States. The FDA's PreCheck program comes amid growing concerns over the United States' reliance on foreign drug manufacturing. Currently, more than half of all pharmaceuticals distributed in the U.S. are produced overseas and only 11% of active pharmaceutical ingredient (API) manufacturers for FDA-approved products are based domestically. This overreliance has been identified as a national security risk, particularly in light of recent global supply chain disruptions.
Key Features of the FDA PreCheck Program
The PreCheck program introduces a two-phase approach to facilitate the development of new U.S.-based drug manufacturing facilities:
1. Facility Readiness Phase
During the first phase (known as the "Facility Readiness Phase"), selected manufacturers will have increased opportunities for communication with the FDA at critical development stages, including facility design, construction and pre-production. The FDA encourages companies to submit comprehensive, facility-specific information—such as site layouts, quality system elements and quality management maturity practices—via a Type V Drug Master File (DMF). This DMF can later be referenced in drug applications.
2. Application Submission Phase
The second phase (known as the "Application Submission Phase") is intended to build upon the first phase and will: (1) provide applicants and their manufacturers the opportunity to give FDA advanced awareness of facility and manufacturing strategies for specific drugs in forthcoming applications; (2) enable FDA to provide Chemistry, Manufacturing and Controls (CMC) feedback on anticipated data or logistical needs to support timely review and inspection processes; and (3) allow FDA to accelerate quality element assessments for applications from new U.S. facilities through early facility engagement and frontloaded assessment activities.
Upcoming FDA Public Meeting
To further engage stakeholders and solicit feedback on the FDA's proposal to facilitate the establishment of new pharmaceutical manufacturing facilities in the U.S., the FDA will host a public meeting on September 30, 2025, titled "Onshoring Manufacturing of Drugs and Biological Products." The meeting will be held at the FDA White Oak Campus in Silver Spring, Maryland, with virtual participation options available. As part of the public meeting, the FDA is seeking specific input from interested stakeholders on the following questions:
1. What do you consider the most significant regulatory hurdle in establishing a new domestic pharmaceutical manufacturing facility?
2. Which element(s) described in the FDA PreCheck proposal are most likely to help the establishment of new US pharmaceutical manufacturing facilities?
3. Are there additional elements or implementation considerations that should be considered in the FDA PreCheck proposal?
4. Would your company be willing to provide information about manufacturing facilities relevant to FDA oversight ( e.g., facility design relevant to CGMP compliance, quality systems, processes and controls, qualification or validation data) in advance of, or separate from, an application submission? What concerns might you have about sharing this information outside the context of a drug application?
The FDA is also interested in participants' other ideas relevant to FDA authorities that may help incentivize or strengthen pharmaceutical manufacturing in the U.S.
Implications for Industry
The FDA expects that the PreCheck program will provide greater regulatory predictability and reduce unnecessary delays in the establishment of domestic manufacturing sites. Pharmaceutical companies are already responding to the Administration's push for onshoring, with several major firms announcing significant investments in new and expanded U.S. facilities.
Action Items
Manufacturers considering new or expanded U.S. facilities should review the PreCheck program details and consider early engagement with the FDA. Additionally, interested stakeholders should strongly consider participating in the upcoming public meeting on September 30, 2025, to provide input and learn more about the program's implementation. For questions about how the FDA PreCheck program may impact your organization or for assistance in preparing for the public meeting (including the submission of comments), please contact our FDA regulatory team.
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