FDA Speeds Drug Checks with Pandemic-Inspired Alternative Tools Guidance
Published Date: 9/12/2025
Notice
Summary
The FDA just released new guidance to help drug makers and applicants understand how the agency will use alternative tools to check drug manufacturing facilities listed in their applications. This change speeds up reviews by using smart methods learned during the COVID-19 pandemic, affecting anyone submitting new drug or biologic applications. These updates start now and aim to make the process smoother without extra costs.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
FDA Uses Alternative Tools for Facility Checks
The FDA issued final guidance on how it will use alternative tools to assess drug manufacturing facilities named in marketing applications like NDAs, ANDAs, and BLAs (and supplements). The guidance finalizes the draft issued on September 22, 2023, implements best practices from tools used during the COVID-19 pandemic, and is now available to applicants. The document is tied to PDUFA VII and BsUFA III (Fiscal Years 2023 through 2027) and aims to make the review process smoother without extra costs.
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