Remember certain GDUFA fees were assessed on October 1, 2017 including the new FDA program fee and establishment fees. The FDA published arrears lists today and there are a lot of folks on those lists. If there is an error or if you need to pay the fee you should either rectify the situation quickly or pay the owed fee. Failure to take action could mean that FDA will not accept any new ANDAs from you or in some instances that all of your approved products could be considered to be misbranded.
Check out the lists here and be certain to address the listings.
