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# FDA REMS Standards Need Assessment
- URL: https://www.fdaweb.com/fda-rems-standards-need-assessment/
- Published: 2017-07-17T12:00:00.000Z
- Updated: 2026-09-14T22:34:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139153

FDA has posted a “REMS Platform Standards Initiative: Needs Assessment” [document](https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM565594.pdf?ref=fdaweb.com) that is intended to help standardize risk evaluation and mitigation strategies (REMS) with elements to assure safe use, and better integrate them into the growing electronic healthcare system. The initiative is intended to support data standards development to facilitate communication between REMS and their participants. Once the standards are developed, FDA would maintain a list of REMS platform standards and encourage their use in REMS. The agency says the purpose of this document is to “provide REMS stakeholders, standards developers, and health information technology systems developers with specific, detailed information on the areas in which standards development is needed and the information that the data standards would need to communicate.”