FDA Launches PreCheck Pilot Program to Bolster Domestic Drug Manufacturing

FDA has officially launched its PreCheck Pilot Program, which is designed to bolster the domestic pharmaceutical supply chain by streamlining the regulatory assessment process for manufacturing facilities based in the United States.1 By providing enhanced regulatory predictability and early engagement, the program aims to facilitate the construction of domestic sites and expedite the evaluation of manufacturing elements before a specific product application is even filed.

Is this a strategic shift toward onshoring?

FDA Commissioner Marty Makary, M.D., M.P.H., characterized the program as a “bold step” to bring manufacturing back to the US and make the domestic sector more resilient and competitive. This program is positioned as one of several incentives the agency is deploying to strengthen the nation's drug supply.

“After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back," said FDA Commissioner Marty Makary, M.D., M.P.H, in the press release.1 “The PreCheck program is one of several powerful incentives we are providing to make the US pharmaceutical manufacturing sector more resilient and competitive.”

The two-phase framework

The PreCheck program is structured into two distinct phases to ensure comprehensive support throughout the facility development lifecycle (see Table).

What are the selection criteria?

The agency will begin conducting PreCheck activities with an initial cohort of new facilities in 2026. Selection for the program is competitive and based on alignment with national priorities.

FDA will evaluate applicants based on the following criteria:

• Product type. Facilities producing critical medications for the US market will receive priority consideration.

• Development stage. The current phase of facility development and the projected timeline for reaching the US market.

• Innovation. A focus on innovative approaches to facility development and manufacturing processes.

What role did industry feedback play?

The design of PreCheck is not a top-down mandate but a reflection of extensive industry collaboration, according to the agency. FDA incorporated feedback from a public meeting held on Sept. 30, 2025, titled “Onshoring Manufacturing of Drugs and Biological Products”. Industry stakeholders expressed strong support for early engagement during facility development and the implementation of streamlined documentation processes, both of which are now core components of the PreCheck model.

What does this mean for manufacturers?

Onshoring efforts may be driven by a need to mitigate the risks associated with global logistics and “just-in-time” supply chains. Companies wishing to establish new API manufacturing facilities may face regulatory roadblocks including inspection predictability and post-approval flexibility.2

Manufacturers interested in participating in the 2026 program should review the eligibility and selection criteria on the official FDA PreCheck web page. The agency is currently accepting requests to participate as of Feb. 1, 2026.

References

1. FDA. FDA Launches PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturing. Press release. Feb. 1, 2026. https://www.fda.gov/news-events/press-announcements/fda-launches-precheck-pilot-program-strengthen-domestic-pharmaceutical-manufacturing
2. Schwartz, M.I. and Kim, J. Onshoring Drug Manufacturing. Insights from FDA’s PreCheck Initiative and Public Meeting. TheFDALawBlog.com. Oct. 28, 2025. https://www.thefdalawblog.com/2025/10/onshoring-drug-manufacturing-insights-from-fdas-precheck-initiative-and-public-meeting