federal_register: 2017-21218

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2017-21218 Range of Risk Evaluation and Mitigation Strategies Platform Standards Initiative: Needs Assessment; Request for Comments Notice The Food and Drug Administration (FDA or the Agency) is seeking public input on the design of the REMS Platform Standards Initiative, as well as methods and best practices for its construction. To facilitate this, FDA is making available the "REMS Platform Standards Initiative: Needs Assessment" (needs assessment), which summarizes a range of risk evaluation and mitigation strategies (REMS) activities that could be standardized and integrated into the health care system through the use of electronic data standards. 2017-10-03 2017 10 https://www.federalregister.gov/documents/2017/10/03/2017-21218/range-of-risk-evaluation-and-mitigation-strategies-platform-standards-initiative-needs-assessment https://www.govinfo.gov/content/pkg/FR-2017-10-03/pdf/2017-21218.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is seeking public input on the design of the REMS Platform Standards Initiative, as well as methods and best practices for its construction. To facilitate this, FDA is making available the "REMS...

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