title: Regulatory watch: Why do oncology drugs fail to gain US regulatory approval?
authors.affiliation: Center for Drug Evaluation and Research, Silver Spring, Maryland 20993, USA.
authors.forename: Sean
authors.initials: S
authors.lastname: Khozin
authors.affiliation: Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
authors.forename: Ke
authors.initials: K
authors.lastname: Liu
authors.affiliation: Center for Drug Evaluation and Research, Silver Spring, Maryland 20993, USA.
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Jarow
authors.affiliation: Center for Drug Evaluation and Research, Silver Spring, Maryland 20993, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Pazdur
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D015507:Drugs, Investigational / Q000627:therapeutic use*; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy* / Q000453:epidemiology; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D000970:Antineoplastic Agents; D015507:Drugs, Investigational