FDA Guidance for Industry: Format and Content of a REMS Document

Titel:
FDA Guidance for Industry: Format and Content of a REMS Document
Herkunft/Verlag:

FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf

Inhalt:
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

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