Anatomy of risk evaluation and mitigation strategies (REMS)

Kari K. Loeser; June M McKoy; Glen T. Schumock

doi:10.1007/978-3-319-43896-2_7

Anatomy of risk evaluation and mitigation strategies (REMS)

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

^*Corresponding author for this work

Medicine, Geriatrics Division

Research output: Chapter in Book/Report/Conference proceeding › Chapter

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 Topics covered include the 2015 Draft Guidance, organization structure and functions, a discussion on pharmacovigilance and adverse event reports, and a discussion of the applicability of REMS in oncology.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 language	English (US)
Title of host publication	Cancer Treatment and Research
Publisher	Springer International Publishing
Pages	93-105
Number of pages	13
DOIs	https://doi.org/10.1007/978-3-319-43896-2_7
State	Published - Jan 1 2019

Publication series

Name	Cancer Treatment and Research
Volume	171
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

Access to Document

10.1007/978-3-319-43896-2_7

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