Anatomy of risk evaluation and mitigation strategies (REMS)

Kari K. Loeser*, June M McKoy, Glen T. Schumock

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

This Chapter provides an introduction and overview of the U.S. FDA REMS program and applicable regulatory aspects. Topics covered include the 2015 Draft Guidance, organization structure and functions, a discussion on pharmacovigilance and adverse event reports, and a discussion of the applicability of REMS in oncology.

Original languageEnglish (US)
Title of host publicationCancer Treatment and Research
PublisherSpringer International Publishing
Pages93-105
Number of pages13
DOIs
StatePublished - Jan 1 2019

Publication series

NameCancer Treatment and Research
Volume171
ISSN (Print)0927-3042

Keywords

  • CDER
  • Mitigation
  • OPDP
  • Oncology
  • Pharmaceuticals
  • Prescription drugs
  • REMS
  • Risk evaluation
  • U.S. food and drug administration (FDA)

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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