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GUIDANCE DOCUMENT

CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality July 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2018-D-4417
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance describes a program at FDA’s Center for Drug Evaluation and Research (CDER) to make public a comprehensive listing of recognized voluntary consensus standards related to pharmaceutical quality. FDA’s participation in the development and use of technical voluntary consensus standards has been integral to the execution of FDA’s mission. For example, FDA has used such standards to develop and/or evaluate performance characteristics of dosage forms, testing methodologies, manufacturing practices, product standards, scientific protocols, ingredient specifications, labeling of drug products, and other technical or policy criteria.

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All written comments should be identified with this document's docket number: FDA-2018-D-4417.

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