US FDA's GDUFA-Related FTEs Increase … Except In CBER
Employees performing generic drug user fee program and related work increased nearly 68% between FY 2014 and FY 2018; Costs, as well as dependence on fees to pay for them, also increased during the period.
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The record number of full ANDA approvals also exceeded submissions for the first time since GDUFA was enacted.
CDER director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.