Home » FDA Moves to Disqualify Ketek Trial Investigator
FDA Moves to Disqualify Ketek Trial Investigator
April 15, 2010
Another investigator involved in a study of Sanofi-Aventis’ antibiotic
Ketek is facing disciplinary action. The FDA sent Keith Pierce, who conducted a Ketek trial at the Michigan Institute of Medicine, a Notice of Initiation
of Disqualification Proceeding and Opportunity to Explain letter March
17, claiming he submitted false information to the sponsor. The 2003 trial compared Ketek (telithromycin) with GlaxoSmithKline’s Augmentin (amoxicillin/clavulanate
potassium) in outpatients with respiratory tract infections.
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