BioCentury
ARTICLE | Regulation

Choice liberates

FDA handling of Theravance's Vibativ may signal new flexibility on antibiotics

December 3, 2012 8:00 AM UTC

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...