Question: what is gdufa goal date?
Answer: FDA has assigned the GDUFA II goal date of July 31, 2018, consistent with the Commitment Letter, to ensure that GDUFA I ANDAs that did not have goal dates are treated fairly vis-a-vis ANDAs that receive goal dates under GDUFA II, i.e., no later than as if the application/amendment were resubmitted on October 1, 2017.