FDAnews Drug Daily Bulletin

FDA Holds Steady, Looks for More (Drug Wonks blog)
“The House Energy and Commerce Committee is expected to vote this week on a bill that would allow FDA to collect newly enacted generic drug user fees,” blogger Peter Pitts writes. The House last week passed a continuing resolution, extending funding at current levels, “but omitted technical language that would have allowed the FDA to benefit from an increase in drug and medical device user fees and to spend the newly enacted user fees for biosimilars and generics,” Pitts adds. The FDA hopes use $299 million from new generic drug user fees in Fiscal 2013 to reduce huge application backlogs, increase postmarket safety oversight and ramp up inspections of generic drug manufacturers outside the U.S.