title: Regulatory Watch: Impact of breakthrough therapy designation on cancer drug development.
authors.affiliation: Friends of Cancer Research, 1800 M St NW, Suite 1050 South, Washington DC 20036, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Shea
authors.affiliation: Friends of Cancer Research, 1800 M St NW, Suite 1050 South, Washington DC 20036, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: Ostermann
authors.affiliation: Friends of Cancer Research, 1800 M St NW, Suite 1050 South, Washington DC 20036, USA.
authors.forename: Ryan
authors.initials: R
authors.lastname: Hohman
authors.affiliation: Friends of Cancer Research, 1800 M St NW, Suite 1050 South, Washington DC 20036, USA.
authors.forename: Samantha
authors.initials: S
authors.lastname: Roberts
authors.affiliation: Friends of Cancer Research, 1800 M St NW, Suite 1050 South, Washington DC 20036, USA.
authors.forename: Marina
authors.initials: M
authors.lastname: Kozak
authors.affiliation: Friends of Cancer Research, 1800 M St NW, Suite 1050 South, Washington DC 20036, USA.
authors.forename: Ryan
authors.initials: R
authors.lastname: Dull
authors.affiliation: Friends of Cancer Research, 1800 M St NW, Suite 1050 South, Washington DC 20036, USA.
authors.forename: Jeff
authors.initials: J
authors.lastname: Allen
authors.affiliation: Friends of Cancer Research, 1800 M St NW, Suite 1050 South, Washington DC 20036, USA.
authors.forename: Ellen
authors.initials: E
authors.lastname: Sigal
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods; D055808:Drug Discovery / Q000331:legislation & jurisprudence* / Q000379:methods; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D000970:Antineoplastic Agents