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GUIDANCE DOCUMENT

Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry June 2015

Download the Draft Guidance Document
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2015-D-1659
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance has been developed to address the lack of clarity with respect to what chemistry, 17 manufacturing, and controls (CMC) information in a marketing application constitutes an 18 established condition or a “regulatory commitment” that, if changed following approval, requires 19 reporting to FDA. Clarification regarding which elements of the CMC information constitute 20 established conditions and where in an application these elements are generally expected to be 21 described, should lead to a better understanding that certain CMC changes can be made solely 22 under the Pharmaceutical Quality System (PQS)2 without the need to report to FDA. For those 23 changes that do require reporting, a better understanding of established conditions could allow 24 for a more effective post-approval submission strategy by the regulated industry.

Submit Comments

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-2015-D-1659.

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