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 Topics covered include the 2015 Draft Guidance, organization structure and functions, a discussion on pharmacovigilance and adverse event reports, and a discussion of the applicability of REMS in oncology.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).
MeSH terms
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Adverse Drug Reaction Reporting Systems* / legislation & jurisprudence
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Adverse Drug Reaction Reporting Systems* / organization & administration
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Drug-Related Side Effects and Adverse Reactions
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Humans
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Neoplasms / drug therapy*
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Pharmacovigilance*
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Risk Evaluation and Mitigation* / legislation & jurisprudence
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Risk Evaluation and Mitigation* / organization & administration
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Risk Management / legislation & jurisprudence
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Risk Management / organization & administration
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United States
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United States Food and Drug Administration / legislation & jurisprudence
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United States Food and Drug Administration / organization & administration