The FDA and the case of Ketek.
Ross
David B
DB
George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
D026683:Advisory Committees; D000900:Anti-Bacterial Agents / Q000009:adverse effects*; D056486:Chemical and Drug Induced Liver Injury; D002986:Clinical Trials as Topic / Q000592:standards*; D017277:Drug Approval; D006801:Humans; D048628:Ketolides / Q000009:adverse effects*; D017114:Liver Failure, Acute / Q000139:chemically induced* / Q000401:mortality; D018579:Patient Selection; D015871:Scientific Misconduct; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000458:organization & administration*
D000900:Anti-Bacterial Agents; D048628:Ketolides; C106791:telithromycin