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 Topics covered include the 2015 Draft Guidance, organization structure and functions, a discussion on pharmacovigilance and adverse event reports, and a discussion of the applicability of REMS in oncology.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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

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

Cite this

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AU - Schumock, Glen T.

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 Topics covered include the 2015 Draft Guidance, organization structure and functions, a discussion on pharmacovigilance and adverse event reports, and a discussion of the applicability of REMS in oncology.

KW - CDER

KW - Mitigation

KW - OPDP

KW - Oncology

KW - Pharmaceuticals

KW - Prescription drugs

KW - REMS

KW - Risk evaluation

KW - U.S. food and drug administration (FDA)

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T3 - Cancer Treatment and Research

SP - 93

EP - 105

BT - Cancer Treatment and Research

PB - Springer International Publishing

ER -

Anatomy of risk evaluation and mitigation strategies (REMS)

Abstract

Publication series

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

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