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GUIDANCE DOCUMENT

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

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-1995-D-0288
Issued by:
Guidance Issuing Office
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  This guidance finalizes the draft guidance, “Chemistry, Manufacturing, and Controls Changes to an Approved Application:  Certain Biological Products” dated December 2017, and supersedes the guidance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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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1995-D-0288.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
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