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Finding, evaluating, and managing drug‐related risks: approaches taken by the US Food and Drug Administration (FDA)
Author(s) -
Weaver Joyce,
Grenade Lois La,
Kwon Hyon,
Avigan Mark
Publication year - 2009
Publication title -
dermatologic therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.595
H-Index - 68
eISSN - 1529-8019
pISSN - 1396-0296
DOI - 10.1111/j.1529-8019.2009.01233.x
Subject(s) - medicine , postmarketing surveillance , pharmacovigilance , food and drug administration , drug , clinical trial , adverse effect , new drug application , adverse event reporting system , pharmacogenomics , off label use , pharmacology
Marketed pharmaceuticals are evaluated for safety by the US Food and Drug Administration (FDA) throughout the life cycle of the products. The FDA uses data from controlled clinical trials, from postmarketing case reports reported to the FDA's Adverse Event Reporting System, from epidemiological studies, and from registries to evaluate the safety of approved products. For some products, including some products used in dermatologic medicine, risks become apparent during the postmarketing period that require additional measures beyond product labeling and routine pharmacovigilance. The FDA continues to seek additional tools to assess risk, including pharmacogenomic biomarkers for adverse drug reactions and the use of large medical record and epidemiological databases for the systematic detection and characterization of drug‐associated safety outcomes.