US FDA's Submission And Review Estimates For 2020
Executive Summary
US FDA's FY 2020 budget request include estimates of new, generic and OTC drug reviews and approvals, although some estimates may not represent the agency's expectations.
The US FDA's FY 2020 budget request congressional justification includes surprisingly anemic projections for application submissions and assessments. While some of the estimates may appear to suggest volume declines are expected, the agency clarified that in some cases its estimates were not the agency's expectations and that a new workload prediction model is under construction to improve accuracy. (Also see "Rounding Up And Down: Assessing FDA FY 2019 and FY 2020 Workload Estimates" - Pink Sheet, 22 Apr, 2019.) Below is a graphic with selected data from the justification documents,