Expediting drug development--the FDA's new "breakthrough therapy" designation

N Engl J Med. 2013 Nov 14;369(20):1877-80. doi: 10.1056/NEJMp1311439.


The FDA's new "breakthrough therapy" designation for investigational drugs adds to the agency's portfolio of expedited programs for serious conditions. The designation requires preliminary clinical evidence demonstrating substantial improvement over existing therapies.

MeSH terms

  • Drug Approval / legislation & jurisprudence*
  • Drugs, Investigational*
  • Humans
  • Time Factors
  • United States
  • United States Food and Drug Administration


  • Drugs, Investigational