FDA Issues Final Guidance on Assessing Drug Manufacturing Facilities Using Alternative Tools

10th October 2025

FDA Issues Final Guidance on Assessing Drug Manufacturing Facilities Using Alternative Tools

On 23rd September 2025, the U.S. Food and Drug Administration (FDA) released final guidance detailing the use of alternative tools to assess drug manufacturing facilities named in marketing applications, including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs). This guidance, developed in response to commitments under the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Act (BsUFA III), aims to enhance regulatory flexibility and efficiency. The FDA outlines a risk-based approach for employing alternative tools such as remote regulatory assessments (RRAs), remote interactive evaluations (RIEs), and inspections conducted by trusted foreign regulatory partners. These methods, which gained prominence during the COVID-19 pandemic, are now integrated into routine operations to support timely application reviews and ensure compliance with Current Good Manufacturing Practice (CGMP) standards. The guidance specifies that these alternative tools are not inspections but serve to complement traditional on-site evaluations, particularly when travel restrictions or other constraints impede physical inspections. 

Link: Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications

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