The FDA Breakthrough-Drug Designation - Four Years of Experience

N Engl J Med. 2018 Apr 12;378(15):1444-1453. doi: 10.1056/NEJMhpr1713338.
No abstract available

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-Infective Agents / therapeutic use
  • Clinical Trials as Topic / methods
  • Drug Approval / legislation & jurisprudence
  • Drug Approval / statistics & numerical data*
  • Drug Discovery
  • Drug Industry / statistics & numerical data*
  • Drugs, Investigational / therapeutic use*
  • Humans
  • Investigational New Drug Application / legislation & jurisprudence
  • Neoplasms / drug therapy
  • Rare Diseases / drug therapy
  • United States
  • United States Food and Drug Administration*

Substances

  • Anti-Infective Agents
  • Drugs, Investigational