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


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 Topics covered include the 2015 Draft Guidance, organization structure and functions, a discussion on pharmacovigilance and adverse event reports, and a discussion of the applicability of REMS in oncology.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
Number of pages13
StatePublished - Jan 1 2019

Publication series

NameCancer Treatment and Research
ISSN (Print)0927-3042


  • 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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