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  1. Electronic Regulatory Submission and Review

Data Standards Manual (monographs)

The FDA Data Standards Manual (DSM) is a compilation of standardized nomenclature monographs that have been reviewed and approved by the FDA Data Standards Council through their Vocabulary Standards Work Group (VSWG) and through CDER Nomenclature Standards Committee (NSC). These nomenclature standards are considered binding upon all new automated databases, and upon all existing automated databases when undergoing a major redesign.

DSM monographs have been jointly developed by several FDA organizational components after a vetting by subject matter experts. DSM monographs may have been derived either wholly or in part from other nomenclature standards settings bodies, as well, such as the American Hospital Formulary Service (AHFS), the American Society for Testing and Materials (ASTM), the Central Intelligence Agency, the Chemical Abstracts Service (CAS), the Clinical Data Interchange Standards Consortium (CDISC), the Consolidated Health Informatics initiative (CHI), the Department of Veterans Affairs, Federal Medical Terminologies (FMT), Health Level Seven (HL7), the Healthcare Information Technology Standards Panel (HITSP), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), the International Organization for Standardization (ISO), the National Institutes of Standards and Technology (NIST), the United States Adopted Names Council (USAN), the United States Census Bureau, the United States Pharmacopeia (USP), and the United States Postal Service.

In 2013, CDER officially phased out use of the CDER-maintained Data Standards Manual (monographs) in favor of using recognized data standards from SDOs. The original monographs have been consolidated and archived, retired, or subsumed by other data standards sources. For the status of a specific monograph, please follow the corresponding link on the left. If you would like to find information or propose a change on the current data standards, please follow the corresponding instructions at CDER Data Standards Program.

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