New FDA Q&A Guidance Addresses Changes to Disposable Manufacturing Materials in Drug and Biological Product Manufacturing

August 02, 2022

The Food and Drug Administration released a new question-and-answer guidance on July 26 that describes post-approval changes related to disposable manufacturing materials and drug and biological product manufacturing.

The guidance applies to biologics license application (BLA) products, human drug products marketed as new drug applications or abbreviated new drug applications, and animal drugs. “Appendix B” in the guidance provides examples of potentially relevant changes and corresponding reporting categories for BLA products.

Interested individuals may submit comments on the guidance. All written comments should be identified with this document's docket number: FDA-2017-D-6821.