> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Draft Guidance on Determining When REMS is Necessary
- URL: https://www.fdaweb.com/draft-guidance-on-determining-when-rems-is-necessary/
- Published: 2016-09-21T12:00:00.000Z
- Updated: 2026-09-14T21:34:05.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136871

*Federal Register* Notice: FDA has released a draft guidance entitled “FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary.” The document is intended to clarify how the agency applies certain factors in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks. To view the guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM521504.pdf?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-09-21/pdf/2016-22689.pdf?ref=fdaweb.com).