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# Factors on REMS Necessity Guidance
- URL: https://www.fdaweb.com/factors-on-rems-necessity-guidance/
- Published: 2019-04-04T12:00:00.000Z
- Updated: 2026-09-15T01:18:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143786

FDA has issued a guidance, *REMS: FDA’s Application of Statutory Factors in Determining When a REMS is Necessary*, to clarify how the agency applies the factors from the Federal Food, Drug, and Cosmetic Act to determine whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks. Issuance of the [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM521504.pdf?utm%5Fcampaign=FDA%20issues%20final%20guidance%20for%20Industry%20on%20FDA%E2%80%99s%20Application%20of%20Statutory%20Factors&utm%5Fmedium=email&utm%5Fsource=Eloqua) fulfills an FDA performance goal under PDUFA 5.

Contents of the document include Introduction, Background, Managing Drug Risks, The Use of REMS in Managing Drug Risks, Application of Statutory Factors in REMS Decision-Making, and Additional Considerations: Potential Burden on the Health Care Delivery System and Patient Access.

The guidance finalizes a 2016 draft.