FDA Faces Dueling Demands On Antibiotic Clinical Trials

Law360, New York (August 8, 2013, 2:34 PM EDT) -- Top pharmaceutical companies in letters released Wednesday implored the U.S. Food and Drug Administration to relax clinical trial standards in order to tackle an emerging public health crisis surrounding declining effectiveness of antibiotics, but consumer groups are pushing back hard, warning of safety risks.

The competing sentiments arose in response to an FDA request for input on new approaches it should consider to help give patients more options for antibacterial drugs, which have been developed less commonly in recent years while at the same time resistance...
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