title: The FDA's generic-drug approval process: similarities to and differences from brand-name drugs.
authors.affiliation: Department of Internal Medicine, Northeast Ohio Medical University, Rootstown, Ohio, USA. chkefalas@att.net
authors.forename: Costas H
authors.initials: CH
authors.lastname: Kefalas
authors.forename: Arthur A
authors.initials: AA
authors.lastname: Ciociola
mesh_terms: D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D017277:Drug Approval / Q000379:methods*; D004348:Drug Labeling / Q000592:standards; D016568:Drugs, Generic / Q000008:administration & dosage / Q000494:pharmacology*; D005260:Female; D006801:Humans; D008297:Male; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D012680:Sensitivity and Specificity; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*
chemical_list: D016568:Drugs, Generic; D004364:Pharmaceutical Preparations