Tuesday, 12 December 2023 14.00 - 16.00 h
FDA issued a new draft guidance document on the potential use of alternative tools in preparation for, or in lieu of, inspection in pending applications: "Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications".
Here, the FDA wants to use a risk-based approach to make necessary decisions, such as requesting additional documentation, remote assessments or using information from other authorities.
According to the FDA, this is intended to provide "operational flexibility" to facilitate timely approval of drugs. These alternative tools complement inspections but are not considered as such. This guidance does not apply to other inspection programmes, such as post-approval inspections, surveillance inspections, follow-up and compliance inspections.
The document is still in draft form and comments can be submitted online.
In this context, FDA had developed and published a Draft Guidance for Industry last year: "Conducting Remote Regulatory Assessments - Questions and Answers". This document is intended to provide answers to frequently asked questions related to RRAs and ultimately facilitate the FDA's process for conducting remote assessments.