Issue Date: July 26, 2023
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural, Drug Competition Action Plan
Status: Final
CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality
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.
Download the Guidance Document
