The FDA and the case of Ketek

N Engl J Med. 2007 Apr 19;356(16):1601-4. doi: 10.1056/NEJMp078032.
No abstract available

MeSH terms

  • Advisory Committees
  • Anti-Bacterial Agents / adverse effects*
  • Chemical and Drug Induced Liver Injury
  • Clinical Trials as Topic / standards*
  • Drug Approval*
  • Humans
  • Ketolides / adverse effects*
  • Liver Failure, Acute / chemically induced*
  • Liver Failure, Acute / mortality
  • Patient Selection
  • Scientific Misconduct*
  • United States
  • United States Food and Drug Administration / legislation & jurisprudence
  • United States Food and Drug Administration / organization & administration*

Substances

  • Anti-Bacterial Agents
  • Ketolides
  • telithromycin