provided in the SDTM TS domain when a full TS is indicated. The information should be provided as one or more records in TS, where TSPARMCD= PCLAS. Pharmacologic class is a complex concept that is made up of one or more component concepts: mechanism of action (MOA), physiologic effect (PE), and chemical structure (CS).51 The established pharmacologic class is generally the MOA, PE, or CS term that is considered the most scientifically valid and clinically meaningful. Sponsors should include in TS (the full TS) the established pharmacologic class of all active moieties of investigational products used in a study. FDA maintains a list of established pharmacologic classes of approved moieties.52 If the established pharmacologic class is not available for an active moiety, then the sponsor should discuss the appropriate MOA, PE, and CS terms with the review division. For unapproved investigational active moieties where the pharmacologic class is unknown, the PCLAS record may not be available." https://www.fda.gov/media/136460/download The United States Food and Drug Administration publishes a Data Standards Catalog that lists the data standards and terminologies that FDA supports for use in regulatory submissions to better enable the evaluation of safety, effectiveness, and quality of FDA-regulated products. In addition, the FDA has the statutory and regulatory authority to require certain standards and terminologies and these are identified in the Catalog with the date the requirement begins and, as needed, the date the requirement ends, and information sources. The submission of data using standards or terminologies not listed in the Catalog should be discussed with the Agency in advance. Where the Catalog expresses support for more than one standard or terminology for a specific use, the sponsor or applicant may select one to use or can discuss, as appropriate, with their review division. Version 7.0 of the FDA Data Standards Catalog dated 03-15-2021, specifies that MED-RT was a required terminology by the White House Consolidated Health Informatics Initiative in various Federal Register Notices beginning as early as May 6, 2004, for NDAs, ANDAs, and certain BLAs beginning on December 17, 2016, and for certain IND's beginning on December 17, 2017. https://www.fda.gov/media/85137/download Medical Devices Global Medical Device Nomenclature (GMDN), the standard international naming system for medical devices. Other Classification of Pharmaco-Therapeutic Referrals (CPR) Logical Observation Identifiers Names and Codes (LOINC), standard for identifying medical laboratory observations MEDCIN, point-of-care terminology, intended for use in Electronic Health Record (EHR) systems Medical Dictionary for Regulatory