ANDA Application Backlogs, Submission Bubbles Plague User Fee Rollout
FDA says in its first GDUFA performance report to Congress that it met all statutory requirements in fiscal year 2013, but while the agency worked on several FY 2013 applications, it did not approve an original ANDA submitted that year.
You may also be interested in...
The U.S. FDA’s Office of Generic Drugs restructures again and adds specialist who helped relieve supplement backlog to improve ANDA review process.
The agency was expecting many pending generic drug submissions to be withdrawn because sponsors would not want to pay the one-time backlog fee, but instead saw a substantial increase near the end of FY 2012.
Government Accountability Office also finds that US FDA review divisions are largely consistent in their assessment times after controlling for goal dates and expedited programs.