title: The generic drug approval process.
authors.affiliation: U.S. Food and Drug Administration, Rockville, Maryland.
authors.forename: P H
authors.initials: PH
authors.lastname: Rheinstein
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods; D016527:Drug Costs; D016568:Drugs, Generic / Q000191:economics / Q000592:standards* / Q000600:supply & distribution; D005607:Fraud; D010330:Patents as Topic / Q000331:legislation & jurisprudence; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016568:Drugs, Generic