title: Finding, evaluating, and managing drug-related risks: approaches taken by the US Food and Drug Administration (FDA).
abstract: 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.
authors.affiliation: Division of Risk Management, Office of Surveillance and Epidemiology CDER, FDA, Silver Spring, Maryland 20933, USA.
authors.forename: Joyce
authors.initials: J
authors.lastname: Weaver
authors.forename: Lois La
authors.initials: LL
authors.lastname: Grenade
authors.forename: Hyon
authors.initials: H
authors.lastname: Kwon
authors.forename: Mark
authors.initials: M
authors.lastname: Avigan
mesh_terms: D003879:Dermatologic Agents / Q000627:therapeutic use*; D017277:Drug Approval; D006801:Humans; D012307:Risk Factors; D012308:Risk Management; D012871:Skin Diseases / Q000188:drug therapy* / Q000453:epidemiology*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D003879:Dermatologic Agents