A slowdown in generic drug approvals, along with a stocked application pipeline and increased supplement actions, are predicted for the next two fiscal years, suggesting a shift rather than a reduction in the US Food and Drug Administration workload.
Approval actions, which include tentative and full application clearances, were estimated to drop from 1,171 in FY 2019 to 900 in FY 2020 and then 850 in FY 2021, a 27.4% decrease overall, according to fiscal year 2021