title: FDA's role in making exclusivity determinations.
authors.affiliation: Office of the Chief Counsel, U.S. Food and Drug Administration, Rockville, MD, USA
authors.forename: E H
authors.initials: EH
authors.lastname: Dickinson
mesh_terms: D003132:Commerce / Q000331:legislation & jurisprudence; D017277:Drug Approval; D016568:Drugs, Generic; D006801:Humans; D017387:Investigational New Drug Application; 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