The US Food and Drug Administration has begun accepting requests from those seeking to participate in the FDA PreCheck pilot programme.

Designed to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability, the FDA PreCheck programme facilitates the construction of pharmaceutical manufacturing sites in the US, streamlining facility assessments ahead of a specific product application.

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

The agency will select an initial cohort of new pharmaceutical manufacturing facilities and begin conducting PreCheck activities in 2026. The facilities will be selected based on overall alignment with national priorities across multiple criteria, such as products to be manufactured, phase of facility development, timeline for producing pharmaceutical products for the US market, and innovation in facility development. Additional consideration will be given to facilities producing critical medications for the US market.

The FDA incorporated industry feedback received during the ‘Onshoring manufacturing of drugs and biological products’ public meeting. The industry supported early engagement during facility development and streamlined documentation processes. 

FDA PreCheck consists of two phases. During the ‘Facility readiness phase’, the selected manufacturers will engage with FDA for early technical advice before a facility becomes operational, through reviews and utilisation of a facility-specific drug master file for efficient evaluation of facility-specific elements prior to, and in support of the submission of a drug application. In the ‘Application submission phase’, the FDA and the applicants build upon phase 1 and engage through pre-submission meetings and inspections to resolve issues and expedite the assessments of manufacturing information in a drug application.

(Source: USFDA)

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Published on February 9, 2026