United States. Department of Health and Human Services. issuing body.
United States. Food and Drug Administration. issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
This guidance provides information on how the FDA defines the types of changes to an approved risk evaluation and mitigation strategy (REMS), how application holders2 should submit changes to an approved REMS, 3 and how the FDA will process submissions from application holders for changes to REMS. Specifically, this guidance provides information, as described in section 505- 1(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), on what types of changes to REMS will be considered modifications of the REMS and what types of changes will be considered revisions of the REMS (changes that may be implemented following notification to the FDA). 4 This guidance is issued pursuant to section 505-1(h)(2)(A)(ii), (iii), and (iv) of the FD&C Act and section 1132(c) of Public Law 112-144.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)