Another ANDA Submission Surge Begins
US FDA receives more than 100 ANDAs during the first month of GDUFA year five, suggesting sponsors want the new 10-month review goal and cheaper user fee.
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FY 2016 figure, the highest seen by US FDA under the generic drug user fee program, could be the result of older applications exiting the queue, and may be a sign of progress in dealing with the review backlog.
Only 8% of original ANDAs submitted in the user fee program’s third year were approved on the first cycle, compared with 72% that received a complete response letter.
FDA's Office of Generic Drugs completes its best year of the GDUFA era.