FDA Opens Submissions for PreCheck Pilot Program to Accelerate US Pharmaceutical Manufacturing Facilities

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The FDA announced on February 1, 2026, that it has opened applications for the PreCheck Pilot Program to streamline regulatory reviews and accelerate construction of new US pharmaceutical manufacturing facilities.135

Submissions are accepted until March 1, 2026; FDA will select finalists by April 1, request details by May 1, and finalize selections by June 30, starting engagements July 1.34

The program features two phases:
Phase 1 (Facility Readiness) provides early technical advice via pre-operational reviews and Drug Master Files; Phase 2 (Application Submission) expedites drug application reviews and inspections.145

Eligibility requires a new US facility (not existing or extension) committed to submitting NDA, ANDA, BLA, or DMF, and manufacturing for at least 3 years post-approval.4

Selection prioritizes alignment with national needs like domestic sourcing of APIs/DS, addressing drug shortages, critical medicines, and innovation in facility development.245

Sources:

1. https://news.constructconnect.com/fda-launches-precheck-pilot-to-boost-u.s.-drug-manufacturing-facilities?hs_amp=true

2. https://www.pharmexec.com/view/fda-precheck-domestic-manufacturing-pilot-program

3. https://www.fda.gov/industry/fda-manufacturing-precheck-pilot-program/precheck-pilot-program-submission

4. https://www.fda.gov/industry/fda-manufacturing-precheck-pilot-program

5. https://www.fda.gov/news-events/press-announcements/fda-launches-precheck-pilot-program-strengthen-domestic-pharmaceutical-manufacturing