@inbook{19f33beda31148fea8ace9cc409e08df,
title = "Anatomy of risk evaluation and mitigation strategies (REMS)",
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 Topics covered include the 2015 Draft Guidance, organization structure and functions, a discussion on pharmacovigilance and adverse event reports, and a discussion of the applicability of REMS in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)",
author = "Loeser, {Kari K.} and McKoy, {June M} and Schumock, {Glen T.}",
year = "2019",
month = jan,
day = "1",
doi = "10.1007/978-3-319-43896-2_7",
language = "English (US)",
series = "Cancer Treatment and Research",
publisher = "Springer International Publishing",
pages = "93--105",
booktitle = "Cancer Treatment and Research",
}