Anatomy of Risk Evaluation and Mitigation Strategies (REMS).
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 Topics covered include the 2015 Draft Guidance, organization structure and functions, a discussion on pharmacovigilance and adverse event reports, and a discussion of the applicability of REMS in oncology.
['Loeser|Kari K|KK|', 'McKoy|June M|JM|', 'Schumock|Glen T|GT|']
D016907:Adverse Drug Reaction Reporting Systems D064420:Drug-Related Side Effects and Adverse Reactions D006801:Humans D009369:Neoplasms D060735:Pharmacovigilance D000073938:Risk Evaluation and Mitigation D012308:Risk Management D014481:United States D014486:United States Food and Drug Administration
Risk evaluation Mitigation REMS Oncology CDER OPDP Pharmaceuticals Prescription drugs U.S. Food and Drug Administration (FDA)