Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Guidance for Industry June 2021

GUIDANCE DOCUMENT

• Docket Number: FDA-1995-D-0288
• Issued by: Center for Biologics Evaluation and Research; Center for Drug Evaluation and Research

We (FDA or Agency) are providing guidance intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA) as specified in Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12) (i.e., post-approval changes) (Refs. 1 and 2).  The guidance describes general and administrative information on evaluating and reporting changes and recommendations for reporting categories based on a tiered-reporting system for specific changes under 21 CFR 601.12.  This guidance finalizes the draft guidance, “Chemistry, Manufacturing, and Controls Changes to an Approved Application:  Certain Biological Products” dated December 2017, and supersedes the guidance entitled “Guidance for Industry:  Changes to an Approved Application: Biological Products” dated 1997 (July 1997 guidance).

 

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