FDA Losing Ground On Foreign Manufacturing Inspections, House Panel Says
Executive Summary
Congress is refocusing its interest on an FDA issue that it has looked at periodically for more than a decade: drug import safety and the agency's failure to modernize its foreign inspections program
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Editor’s Perspective: Is The Ketek Scandal Good For Big Pharma? Generic Biologic Bill Could Suffer
It was not a pretty sight in Room 2123 of the Rayburn House Office Building on Feb. 12, where the House's Energy and Commerce Committee's Oversight and Investigations Subcommittee held a hearing on fraud in the studies of the antibiotic Ketek. The head of Sanofi-Aventis' U.S. R&D had to acknowledge he could not verify that other studies were free from fraud, and committee members lambasted FDA Commissioner Andrew von Eschenbach in absentia