Assessment Times Improve Under GDUFA
Averages likely will increase as more of the cohort is approved, however.
You may also be interested in...
US FDA Begins Building Pharma Industry Activity Prediction Tool
Algorithms are intended to help predict incoming workload, which will be used to help set user fees.
US FDA First-Cycle ANDA Approvals Not Rising Along With Full Clearances
While FDA is on pace to again break its record for full ANDA approvals in FY 2019, the first-cycle approval rate is dropping, as illustrated in our charts.
Rounding Up And Down: Assessing FDA FY 2019 and FY 2020 Workload Estimates
US FDA provides a few hints about upcoming industry application filing volume and the agency's assessment pace in FY 2020 budget documents.