Anatomy of Risk Evaluation and Mitigation Strategies (REMS)

Cancer Treat Res. 2019:171:93-105. doi: 10.1007/978-3-319-43896-2_7.

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 Topics covered include the 2015 Draft Guidance, organization structure and functions, a discussion on pharmacovigilance and adverse event reports, and a discussion of the applicability of REMS in oncology.

Keywords: CDER; Mitigation; OPDP; Oncology; Pharmaceuticals; Prescription drugs; REMS; Risk evaluation; U.S. Food and Drug Administration (FDA).

Publication types

  • Review

MeSH terms

  • Adverse Drug Reaction Reporting Systems* / legislation & jurisprudence
  • Adverse Drug Reaction Reporting Systems* / organization & administration
  • Drug-Related Side Effects and Adverse Reactions
  • Humans
  • Neoplasms / drug therapy*
  • Pharmacovigilance*
  • Risk Evaluation and Mitigation* / legislation & jurisprudence
  • Risk Evaluation and Mitigation* / organization & administration
  • Risk Management / legislation & jurisprudence
  • Risk Management / organization & administration
  • United States
  • United States Food and Drug Administration / legislation & jurisprudence
  • United States Food and Drug Administration / organization & administration