FDA on Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry (from Catapult’s regulatory round-up for september 2023)

This draft guidance, within the context of FDA approval and license decisions, describes the use of alternative tools to assess manufacturing facilities identified in an NDA, an ANDA, or a BLA to establish that these facilities meet the applicable requirements, including under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B). The use of alternative tools will help FDA fulfill its commitments to meet user fee goal dates and to make timely application decisions. Please find information on how to submit comments here.

Published on the 29th of september 2023. Read the entire regulatory round-up here.