FDA - Format and Content of a REMS Document Guidance for Industry for Comment

2nd February 2023

FDA

Format and Content of a REMS Document Guidance for Industry. Now open for comment. 

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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