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GUIDANCE DOCUMENT

CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports March 2014

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2010-D-0283
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes to be documented in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that we have determined will likely have a minimal potential to have an adverse effect on product quality and, therefore, should be documented by applicants in an annual report.

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

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2010-D-0283.

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