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FDA warns Aventis Pharmaceuticals about clinical trial

Pharma Compliance Alert, October 31, 2007

The FDA issued a warning letter to Aventis Pharmaceuticals regarding its role as the sponsor of a clinical trial. The issues addressed in the letter occurred prior to the merger of Sanofi-Synthelabo and Aventis Pharmaceuticals in August 2004.

The study that led to the warning is HMR3647Al3014 (study 3014) entitled "Randomized, Open-Label, Multicenter Trial of the Safety and Effectiveness of Oral Telithromycin [Ketek] and Amoxicillin-Clavulanic Acid [Augmentin] in Outpatients with Respiratory Tract Infections in Usual Care Settings" for the investigational drug Ketek.

Aventis submitted results from Study 3014 to the FDA in July 2002. According to the FDA, data validation of several clinical investigators revealed multiple, significant violations of FDA regulations, including:

• Failure to secure investigator compliance with the investigational plan and applicable FDA regulations
• Failure to ensure proper monitoring of the clinical investigations
• Failure to select qualified investigators and provide investigators with the information needed to conduct the study properly
• Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the investigational new drug application

Click here to read the warning letter.

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