Next Generic Drug User Fee Round Will Tie Fees To Approved Applications

October 21, 2016 at 1:01 PM
The next round of the generic drug user fee program will tie industry fees to approved abbreviated new drug applications as opposed to requiring industry to pay fees when an application is submitted regardless of whether it is approved, FDA said Friday (Oct. 21). FDA also announced the fee will be charged in three tiers rather than a per-ANDA basis, in an effort to align fee responsibility with costs and ability to pay. “We think this is important not only...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.