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.


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