title: New FDA breakthrough-drug category--implications for patients.
authors.forename: Jonathan J
authors.initials: JJ
authors.lastname: Darrow
authors.forename: Jerry
authors.initials: J
authors.lastname: Avorn
authors.forename: Aaron S
authors.initials: AS
authors.lastname: Kesselheim
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D015507:Drugs, Investigational / Q000592:standards* / Q000627:therapeutic use; D006801:Humans; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data
chemical_list: D015507:Drugs, Investigational