FDA Still Under Gun On Antibiotics, Despite Hopeful Signs

Law360, New York (July 11, 2013, 7:08 PM EDT) -- Antibiotic development is showing signs of life after years of hibernation, with multiple drugs becoming eligible for quicker approval and extra exclusivity in the year since Congress created those key incentives, but experts say the U.S. Food and Drug Administration still must eliminate regulatory hurdles to solve the crisis of obsolete antibacterials.

One year ago this week President Barack Obama signed into law a drug user-fee bill that contained the Generating Antibiotic Incentives Now Act. GAIN created a new category of medicines — “qualified infectious disease...
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