FDA announces formal launch of PreCheck program

The US Food and Drug Administration (FDA) officially launched its PreCheck pilot program on Sunday and is now accepting applications from manufacturers who wish to participate. In announcing the program, the agency rejected the pharmaceutical industry’s suggestions to allow existing facilities to participate in the program.

The much-touted program is intended to fulfill a goal of the Trump Administration to promote pharmaceutical manufacturing in the US. The agency announced it will select an initial cohort of new pharmaceutical manufacturing facilities and begin conducting PreCheck activities this year.

"After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back," FDA Commissioner Marty Makary said. "The PreCheck program is one of several powerful incentives we are providing to make the U.S. pharmaceutical manufacturing sector more resilient and competitive."

“Facilities will be selected based on overall alignment with national priorities across multiple selection criteria, such as products to be manufactured, phase of facility development, timeline to producing pharmaceutical products for the U.S. market, and innovation in facility development. Additional priority consideration will be given to facilities producing critical medications for the U.S. market,” FDA wrote.

FDA first announced it was developing the program last August. (RELATED: This Week at FDA: PreCheck manufacturing program, new FDA chief counsel, and more, Regulatory Focus 8 August 2025)

The agency subsequently announced that it was seeking public comments on several questions, including the main regulatory challenges involved in establishing a new pharmaceutical manufacturing facility in the US. (RELATED: FDA seeks feedback on ways to bring manufacturing back to the US, Regulatory Focus 15 August)

In response, pharmaceutical groups requested an expansion of the FDA’s PreCheck program to include both existing and new manufacturing facilities. Additionally, some groups suggested that PreCheck be integrated with current programs. (RELATED: Pharma groups seek expansion of FDA’s PreCheck program, Regulatory Focus 4 November 2025)

FDA stated that it incorporated “extensive” feedback from the industry into the program design. The agency noted that industry strongly supported early engagement during facility development and streamlined documentation processes. However, the industry's request to cover existing facilities was rejected.

Additional information on eligibility criteria and program participation is provided in an update on FDA’s website.

In the section on eligibility criteria, FDA said “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.”

In addition, the program will cover new manufacturing facilities that produce “sufficient volume to meet a specified market need.”

Sponsors must also commit to submitting an original New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA), or application supplement for drug substance (DS) for a finished drug product or a Type II DMF for small molecule APIs for the new manufacturing facility.

Companies must also commit to actively manufacturing products in the facility assessed as part of the pilot program for at least three years after FDA approval.

The pilot program will consist of two-phases: a facility readiness phase, and an application submission phase.

In Phase 1, selected manufacturers can engage with the FDA for early technical advice before their facilities become operational. This engagement includes pre-operational reviews and the use of a facility-specific Drug Master File (DMF), which helps streamline the evaluation of unique facility elements prior to and in support of submitting a drug application.

In Phase 2, FDA and applicants would build upon the foundation laid in Phase 1. During this phase, they conduct pre-submission meetings to address any issues and expedite the assessment of manufacturing information included in the drug application.

FDA announcement; PreCheck program details

FDA announces formal launch of PreCheck program

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