title: FDA's role in administering the Hatch-Waxman Act.
authors.affiliation: Health Assessment Policy Staff, Office of Health Affairs, Food and Drug Administration, USA
authors.forename: B J
authors.initials: BJ
authors.lastname: Malkin
mesh_terms: D017277:Drug Approval; D016568:Drugs, Generic; D006801:Humans; D007880:Legislation, Drug; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016568:Drugs, Generic