GUIDANCE DOCUMENT
Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Guidance for Industry April 2016
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2016-D-0973
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
This guidance provides recommendations to holders of applications for human drugs and biologics on implementing a chemistry, manufacturing, and controls (CMC) postapproval change through the use of a comparability protocol (CP). It replaces the draft guidance that published in February 2003, titled Comparability Protocols: Chemistry, Manufacturing, and Controls Information.
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All written comments should be identified with this document's docket number: FDA-2016-D-0973.