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GUIDANCE DOCUMENT

CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality February 2019

Draft

Not for implementation. Contains non-binding recommendations.

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

Docket Number:
FDA-2018-D-4417
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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, compliance criteria, ingredient specifications, labeling of drug products, and other technical or policy criteria.


Submit Comments

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:

Division of Dockets Management (HFA- 305)
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-2018-D-4417.