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E-mails Question FDA Review Process For Ketek

Law360 (July 19, 2006, 12:00 AM EDT) -- Several recently uncovered e-mails have exposed concern by Food and Drug Administration officials that the agency’s approval of a bronchitis treatment marketed by Sanofi-Aventis was a potentially lethal mistake.

An FDA official, David Graham, sent an e-mail last month questioning the approval of the drug, sold under the name Ketek, and claiming that the review process was fraught with error and oversight, the New York Times reported.

“It's as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin...
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