Burned By Ketek, FDA Took Care With Possible Data Integrity Issues For Telavancin
This article was originally published in Pharmaceutical Approvals Monthly
Congressional investigations into FDA's handling of data integrity issues with a safety trial for Sanofi-Aventis' antibiotic Ketek caught Theravance's pending antibiotic Vibativ (telavancin) in its wake, FDA review documents reveal
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"Several outstanding issues" forced FDA to cancel the meeting, the agency said.