Announced Feb.1, 2026, the FDA is now accepting requests to participate in its new PreCheck Pilot Program, designed to strengthen the U.S. pharmaceutical supply chain and improve regulatory predictability for new domestic manufacturing facilities.

PreCheck enables early FDA engagement during facility development, streamlined manufacturing assessments, and more efficient review of NDAs, ANDAs, BLAs, and certain DMFs—before a product application is submitted.

Facilities producing critical medicines, using U.S.-based sourcing, or leveraging innovative manufacturing approaches will be prioritized.

📌 This pilot could be a major opportunity for companies planning new U.S. manufacturing sites.

Find out if you’re eligible to apply: https://www.fda.gov/industry/fda-manufacturing-precheck-pilot-program

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