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GUIDANCE DOCUMENT

Format and Content of a REMS Document Guidance for Industry January 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2009-D-0461
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance provides updated recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product, including a biological drug product. A REMS document, which is part of a REMS that is required by FDA, establishes the goals and requirements of the REMS.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0461.

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