FDA - FDA Launches PreCheck Program to Strengthen Domestic Drug Manufacturing

11th August 2025

FDA Launches PreCheck Program to Strengthen Domestic Drug Manufacturing

The U.S. Food and Drug Administration (FDA) has launched the FDA PreCheck programme to strengthen the U.S. pharmaceutical supply chain. This initiative aims to boost domestic drug manufacturing by improving regulatory predictability and supporting the establishment of new facilities within the country. Currently, over half of pharmaceuticals sold in the U.S. are made overseas. The PreCheck programme introduces a two-phase process to support new U.S. manufacturing sites, focusing on better communication and early engagement with the FDA during the planning, design, and manufacturing stages. A public meeting to discuss the programme is scheduled for 30th September 2025.

FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing

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