FDA Sends Warning to Maker of Ketek For Study Deception
Sanofi-Aventis, the maker of antibiotic Ketek, received a stern warning letter from the FDA which cited numerous serious violations in the drugmaker's safety study. Referring to the study known as "Study 3014," the FDA wrote, ". . . we conclude that Aventis did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations."
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