FDA Manufacturing PreCheck Pilot Program
Strengthening the domestic pharmaceutical supply chain
Program Overview
FDA PreCheck Program represents a strategic initiative to strengthen America's pharmaceutical supply chain by reducing regulatory barriers for domestic manufacturing facilities. Currently, more than half of pharmaceuticals distributed in the U.S. are manufactured overseas, with only 11% of Active Pharmaceutical Ingredient (API) manufacturers being U.S.-based, creating significant national security vulnerabilities. In response to Executive Order 14293, "Regulatory Relief to Promote Domestic Production of Critical Medicines," FDA hopes to facilitate the development of new U.S. drug manufacturing facilities by streamlining the review and inspection process for new construction manufacturing facilities that will supply finished dosage form (FDF) or API.
Phase I of the PreCheck Pilot Program will select participants who are developing new pharmaceutical manufacturing facilities based on alignment to program priorities and will begin conducting PreCheck activities in 2026. Companies selected for the program will benefit from FDA communication and feedback throughout the facility development process. The PreCheck Pilot Program reflects FDA’s commitment to create more efficient regulatory review processes and ensure access to life-saving medicines for American patients.
We have outlined below the eligibility criteria, selection criteria, submission details, and what companies can expect through program participation.
**Note: For purposes of the PreCheck Pilot Program, “pharmaceutical” includes both drug and biological products unless indicated otherwise.
Key Program Benefits
- FDA collaboration and engagement during the initial facility development phases, not tied to product submissions
- Enhanced communication throughout the facility evaluation process, including the inspection process
- Earlier FDA feedback that ensures continuity with later facility evaluations, including inspections
Submit Your Request to Participate
A resilient supply chain for medical products, and specifically, pharmaceuticals and biological products, is critical for the safety and security of the United States. The globalization of pharmaceutical production over the past several decades complicates these challenges.
Until the 2000’s, pharmaceutical manufacturing was largely a domestic enterprise. In the last several decades, however, such manufacturing has increasingly moved offshore. Today, more than half of the pharmaceuticals distributed in the U.S. are manufactured overseas. As of 2025, approximately 53% of branded drug products and 69% of generic drug products are manufactured outside of the United States. As of 2025, only 11% of API manufacturers are in the U.S., compared to 22% in China and 44% in India.
To help bolster pharmaceutical supply chain resiliency in the U.S., on May 5, 2025, the President issued Executive Order (EO) 14293, “Regulatory Relief to Promote Domestic Production of Critical Medicines.” EO 14293 sets forth a policy intended to streamline the regulation of manufacturing pharmaceutical products to facilitate the restoration of a robust domestic pharmaceutical manufacturing base. EO 14293 directs FDA to review existing regulations and guidance that pertain to the development of domestic pharmaceutical manufacturing and take steps to “eliminate any duplicative or unnecessary requirements…; maximize the timeliness and predictability of agency review; and streamline and accelerate the development of domestic pharmaceutical manufacturing.”
In response to EO 14293, FDA has developed the FDA PreCheck Pilot Program, aimed to accelerate the establishment of high priority new pharmaceutical manufacturing facilities in the U.S. and strengthen the domestic pharmaceutical supply chain. Specifically, the pilot program consists of a two-phase approach: (1) Facility Readiness Phase, and (2) Application Submission Phase. In Phase 1, the Facility Readiness Phase, selected manufacturers can engage with FDA for early technical advice before a facility is operational through pre-operational reviews and utilization of a facility-specific Drug Master File to facilitate efficient evaluation of facility-specific elements prior to, and in support of, the submission of a drug application. In Phase 2, the Application Submission Phase, FDA and applicants build upon Phase 1 and engage through pre-submission meetings to resolve issues and expedite assessments of manufacturing information in a drug application and inspections.
Companies must meet the following requirements to be eligible for the PreCheck Pilot Program. Please note that companies are limited to one submission for a single new manufacturing facility in the U.S.
New manufacturing facility:
A domestic manufacturing facility that is not an existing facility or an extension of an existing facility and has broken ground, will break ground by the pilot full proposal deadline, or is in the pre-operational development intended to produce human drugs and/or biological products.
Located in the United States:
PreCheck Pilot Program will be limited to new manufacturing facilities located in the United States and insular areas.
Facility size thresholds:
New manufacturing facilities that produce sufficient volume to meet a specified market need (for example a small volume may be acceptable if it fully meets the needs for a rare disease state with a limited patient population) or contributes significantly to addressing US market supply needs.
Submission commitments:
Commitment to submit an original New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA), or application supplement for drug substance (DS), FDF/drug product (DP), or a Type II DMF for small molecule APIs for the new manufacturing facility during the PreCheck Pilot Program. Companies also commit to actively manufacturing products in the facility assessed as part of the pilot program for at least 3 years after FDA approval of the products manufactured at that facility during pilot participation.
These criteria highlight U.S. government priorities for new pharmaceutical manufacturing facilities. Submissions should fulfill at least two, but as many as all, of the following criteria to be considered for the PreCheck screening and selection process.
Source:
FDA will prioritize facilities that manufacture U.S. FDFs/DP using U.S. APIs/DS, or U.S. API/DS using U.S. key starting materials. Consideration will be given to PreCheck submissions that can demonstrate a robust approach to domestic sourcing with proven partnerships or internal commitments.
Products:
The PreCheck Program Pilot will consider submissions for a facility that manufactures a variety of products across specializations and therapeutic areas, including APIs/DS, FDFs/DP, sterile injectables, or other specialized pharmaceutical products that strengthen the U.S. pharmaceutical supply chain or improve patient access to novel therapeutics with unmet needs that benefit US patients. Priority consideration for this criterion may be given to facilities producing products that address drug shortages, critical medicines, or key supply chain vulnerabilities, such as sterile drug products, large volume parenterals, or other therapeutically essential medications identified on FDA shortage lists or critical medicine designations. Consideration will be given to facilities designed as a single-product dedicated manufacturing site or a multi-product facility. **Note: FDA reserves the right to limit the number of product specific submissions in Phase 2 and determine an appropriate “graduation” from the program.
Facility development phase:
FDA will prioritize facilities that are in the pre-operational, earlier facility development phases to optimize agency-industry engagement and collaboration, ensuring benefit to both FDA and participants prior to product application submission. Preference will be given to facilities that provide commitments and strategies for participation in the Pre-Operational Review activities and a willingness to provide extensive (non-product) facility specific information in their Type V DMF submission and to participate in potential site visits.
Timeline:
FDA will prioritize facilities demonstrating expeditious execution plans that quantify how participation in this program’s two-phase approach will help them minimize time-to-market for critical pharmaceutical products and contribute to pharmaceutical manufacturing capacity. FDA seeks facilities capable of achieving operational status on an accelerated timeframe using modern technologies or approaches as compared to traditional approaches, as rapid deployment of domestic manufacturing capacity is essential to national security objectives and public health preparedness.
Innovation:
FDA will evaluate facilities’ use of novel approaches to facility design, construction, or implementation that could accelerate development timelines or enhance manufacturing efficiency, such as modular or prefabricated construction methodologies, advanced automation technologies, digital integration, or other methods to enhance facility and manufacturing process innovation. Depending on the technology, engagement with FDA's Emerging Technology Program or CBER Advanced Technologies Team may also be warranted. While only a single facility will be chosen for PreCheck, consideration will be given to facilities designed as replicable templates that could serve as models for expedited construction at scale for the establishment of additional discrete locations, or innovative approaches that demonstrate potential for broader application within the domestic pharmaceutical manufacturing sector. Please note that distributed manufacturing or point of care systems are not in the scope of this pilot.
Company qualifications:
The PreCheck Pilot Program will prioritize companies with past pharmaceutical manufacturing experience, which may be demonstrated through existing commercial facilities, partnerships in place with the appropriate manufacturing experience, or a plan for building the necessary in-house expertise. This may include both large and small manufacturers, and CDMOs that have agreements in place with experienced sponsors and a documented willingness to share information with their proposed partner sponsors about the proposed facility.
Q. What is the purpose of the PreCheck Program?
A. PreCheck aims to strengthen domestic pharmaceutical manufacturing by increasing regulatory predictability. This will be achieved by engaging program participants during development stages of a new manufacturing facility to facilitate alignment between FDA and industry, ultimately streamlining aspects of pharmaceutical manufacturing facility evaluation in advance of a regulatory assessment of specific product applications.
Q. What is the purpose of the Pilot Program?
A. The PreCheck Pilot Program serves as a test model to help identify implementation challenges, establish best practices, and inform critical parameters and potential future scalability. Performance metrics and stakeholder feedback will be systematically evaluated to optimize the PreCheck Pilot Program effectiveness.
Q. When will PreCheck Pilot Program Participants be selected?
A. PreCheck finalists will be notified by April 1, 2026, and final selections will be made by June 30, 2026.
Q. Who will evaluate the requests to participate in the PreCheck Pilot Program?
A. PreCheck requests to participate will be evaluated by relevant CDER & CBER subject matter experts, following the priorities and objective criteria described on the PreCheck submission webpage. Submission of a request to participate is prerequisite to pilot program participation.
Q. Will PreCheck involve FDA facility evaluations of my existing manufacturing facilities?
A. PreCheck is focused on new manufacturing facilities in the U.S. and will not include facility evaluations of existing manufacturing facilities not included in the PreCheck request.
Q. Can a company submit multiple requests to participate for different pharmaceutical manufacturing facilities?
A. No, a company is limited to one request for acceptance into the pilot program for a single pharmaceutical manufacturing facility. However, in reviewing PreCheck requests, FDA will consider whether a facility can be used as a model for future / additional manufacturing facilities the company plans to develop.
Q. How will a company know if they have been selected as a finalist for the PreCheck Pilot Program?
A. Companies will be notified via email if they have been selected as a finalist for the PreCheck Pilot Program and may be asked to submit additional information for FDA to select the final PreCheck Pilot Program participants.
Q. Is participation in the PreCheck Pilot Program mandatory for approval of a product application?
A. No. Participation in PreCheck is voluntary and is not mandatory for approval of any future NDA, BLA, or ANDA submissions.
Q. Does selection for PreCheck guarantee expedited product approval or inspection outcomes?
A. No. PreCheck is intended to facilitate early alignment and regulatory predictability for facility development but does not guarantee expedited product reviews, approvals, or inspection outcomes.
Q. What level of resource commitment is expected from selected participants?
A. Selected participants should expect regular engagement with FDA throughout the pilot period. As such, participants should be prepared to engage with FDA during PreCheck Phase 1 and Phase 2 facility assessment activities by allocating adequate resources, providing timely facility information, and granting access to facility areas during possible site visits.
Q. How many participants will be selected for the initial cohort of the PreCheck Pilot Program?
A. Due to the significant anticipated FDA resource commitment that will be required as part of the pilot program, FDA will select 7 participants for the initial cohort across a variety of facilities/products representing the market. FDA will then refine the PreCheck process using data gathered during the pilot to further enhance the program.
FDA will use responses to the questions in the initial request to participate on this webpage to select finalists for the PreCheck Program Initial Cohort based on alignment with national priorities. FDA will review the initial submissions, and follow up with finalists via email to request additional detailed information to make final selections.
Timeline of Pilot Program Selection:
- March 1: Deadline for companies to submit requests to participate.
- April 1: Deadline for FDA to select PreCheck Program Finalists and request additional detailed information.
- May 1: Deadline for finalists to submit the requested information.
- June 30: Deadline for FDA to review the final submission package and make final selections.
- July 1: Begin pre-operational engagements with PreCheck Pilot initial cohort.
Additional Information
- FDA Announces PreCheck Implementation Roadmap
- FDA Public Meeting: Onshoring Manufacturing of Drugs and Biological Products
- PreCheck Program Announcement