FDA May Be Catching Up With FDAAA Workload, Latest Performance Data Suggests
Executive SummaryPreliminary FDA data indicate the agency may be catching up with the workload imposed by the FDA Amendments Act, with the agency reporting it could meet 10 of 12 review performance goals for NDAs and BLAs submitted in fiscal 2009.
You may also be interested in...
Proposed and existing user fees would fund 44% of the $4.5 billion FDA FY 2013 spending plan. User fees are projected at $20 million for biosimilars and $229 million for generic drugs.