Regulatory Review of New Therapeutic Agents - FDA Versus EMA, 2011-2015

N Engl J Med. 2017 Apr 6;376(14):1386-7. doi: 10.1056/NEJMc1700103.

Publication types

  • Letter

MeSH terms

  • Drug Approval / legislation & jurisprudence
  • Drug Approval / statistics & numerical data*
  • Europe
  • Time Factors
  • United States
  • United States Food and Drug Administration