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. This program facilitates submissions by external stakeholders and FDA staff proposing voluntary consensus standards related to pharmaceutical quality for recognition. CDER believes that this program will help promote beneficial innovation in pharmaceutical development and manufacturing and streamline the preparation and assessment of marketing applications for products regulated by CDER. Even if an industry stakeholder references one of CDER’s recognized voluntary consensus standards to support a product regulated by CDER (e.g., in an application or during an inspection), FDA may request additional information that demonstrates that the standard was followed and is fit for the intended purpose. In addition, the stakeholder’s use of a recognized standard is strictly voluntary. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
The National Library of Medicine believes this item to be in the public domain. (More information)