title: Are Food and Drug Administration prescription drug safety plans working? A case study of isotretinoin.
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Fain
authors.forename: G Caleb
authors.initials: GC
authors.lastname: Alexander
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000517:prevention & control*; D003270:Contraceptive Agents / Q000008:administration & dosage*; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D004363:Drug Utilization / Q000639:trends*; D005260:Female; D006801:Humans; D015474:Isotretinoin / Q000008:administration & dosage* / Q000009:adverse effects*
chemical_list: D003270:Contraceptive Agents; D003879:Dermatologic Agents; D015474:Isotretinoin