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Anatomy of Risk Evaluation and Mitigation Strategies (REMS).
- Source :
-
Cancer treatment and research [Cancer Treat Res] 2019; Vol. 171, pp. 93-105. - Publication Year :
- 2019
-
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 Topics covered include the 2015 Draft Guidance, organization structure and functions, a discussion on pharmacovigilance and adverse event reports, and a discussion of the applicability of REMS in oncology.
- Subjects :
- Drug-Related Side Effects and Adverse Reactions
Humans
Risk Management legislation & jurisprudence
Risk Management organization & administration
United States
United States Food and Drug Administration legislation & jurisprudence
United States Food and Drug Administration organization & administration
Adverse Drug Reaction Reporting Systems legislation & jurisprudence
Adverse Drug Reaction Reporting Systems organization & administration
Neoplasms drug therapy
Pharmacovigilance
Risk Evaluation and Mitigation legislation & jurisprudence
Risk Evaluation and Mitigation organization & administration
Subjects
Details
- Language :
- English
- ISSN :
- 0927-3042
- Volume :
- 171
- Database :
- MEDLINE
- Journal :
- Cancer treatment and research
- Publication Type :
- Academic Journal
- Accession number :
- 30552659
- Full Text :
- https://doi.org/10.1007/978-3-319-43896-2_7