Lessons from the Pandemic: FDA Proposes Permanently Adopting Alternative Tools for Drug Facility Inspections

Lexology November 2, 2023
Ropes & Gray LLP

I. Introduction

On September 22, 2023, FDA issued a new draft guidance titled Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications (the “Alternative Tools in Pending Applications Draft Guidance”). The draft guidance describes alternative regulatory tools FDA used widely during the COVID-19 pandemic and now plans to adopt as regular practices for assessing good manufacturing practice (“GMP”) compliance at drug manufacturing facilities identified in new drug and biologic applications. These tools include remote document assessments, remote interactive evaluations, and reliance on foreign regulatory agency inspection reports.

On October 26th, FDA published a related but separate draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities (the “RIE Draft Guidance”). As the title suggests, this draft...

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