(153) See GAO 11-801, supra note 146, at 11 (outlining Congress reactions to insufficient data collected by FDA and enactment of ADUFA).
As required under the Animal Drug User Fee Amendments of 2008 (ADUFA), the FDA has been collecting and publishing data from pharmaceutical companies regarding antibiotics sold for livestock.
The reauthorization of ADUFA
will generate $98 million in user fees
Collect data already required by drug sponsors to allow health experts to correlate ADUFA
sales/distribution data to resistance data from the National Antimicrobial Resistance Monitoring System (e.g., monthly sales, target species, indications of use and route of administration);
The Animal Drug User Fee Act (ADUFA
) date is set for 25 March 2016.
The company added that the Animal Drug User Fee Act (ADUFA
) date approval for Galliprant is set for 25 March 2o16.