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FDA handling of Theravance's Vibativ may signal new flexibility on antibiotics
Monday, December 3, 2012
The judicious way in which FDA asked its Anti-Infective Drugs
Advisory Committee whether to approve Theravance
Inc.'s Vibativ telavancin to treat hospital-acquired pneumonia last
week may reflect what the agency says is its renewed willingness to work with
industry to overcome hurdles slowing development of antibacterial products.
In the U.S., controversy has
surrounded the infectious disease regulatory landscape for the better part of a
decade as FDA, responding to outside criticism, began requiring more rigorous
antibiotic trial designs.
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