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House panels seek Ketek documents

Executive Summary

Gearing up for their own investigation of FDA's knowledge of safety issues with Sanofi-Aventis Ketek (telithromycin), the House Energy and Commerce Committee and its Oversight and Investigations Subcommittee seek records from the agency on its premarket review and postmarket surveillance of Ketek. Mindful of charges by Sen. Chuck Grassley, R-Iowa, of FDA and HHS obstructionism during the Senate Finance Committee investigation of the antibiotic's approval, the House panels have specified that the documents be unredacted, except in the case of patient identifiers...
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