Anatomy of Risk Evaluation and Mitigation Strategies (REMS).
Adverse Drug Reaction Reporting Systems
/ legislation & jurisprudence
Drug-Related Side Effects and Adverse Reactions
Humans
Neoplasms
/ drug therapy
Pharmacovigilance
Risk Evaluation and Mitigation
/ legislation & jurisprudence
Risk Management
/ legislation & jurisprudence
United States
United States Food and Drug Administration
/ legislation & jurisprudence
CDER
Mitigation
OPDP
Oncology
Pharmaceuticals
Prescription drugs
REMS
Risk evaluation
U.S. Food and Drug Administration (FDA)
Journal
Cancer treatment and research
ISSN: 0927-3042
Titre abrégé: Cancer Treat Res
Pays: United States
ID NLM: 8008541
Informations de publication
Date de publication:
Historique:
entrez:
16
12
2018
pubmed:
16
12
2018
medline:
22
6
2019
Statut:
ppublish
Résumé
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 Topics covered include the 2015 Draft Guidance, organization structure and functions, a discussion on pharmacovigilance and adverse event reports, and a discussion of the applicability of REMS in oncology.
Identifiants
pubmed: 30552659
doi: 10.1007/978-3-319-43896-2_7
doi:
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM