FDA Guidance for Industry: Format and Content of a REMS Document
Title:
FDA Guidance for Industry: Format and Content of
a REMS Document
Origin/Publisher:
FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf
Content:
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