Lexology August 14, 2025
Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.
The August 2025 edition highlights four significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.
FDA’s PreCheck Program Seeks to Facilitate Domestic Drug Manufacturing
What is happening: On August 7 the agency announced a new program, called FDA PreCheck, to provide drug manufacturers with earlier and more frequent interaction with FDA on manufacturing facility design and construction. The intent of the program is to accelerate drug company efforts to establish or expand domestic manufacturing operations.
The PreCheck program consists of two phases:
- The Facility...
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