1. Pink Sheet

US FDA's GDUFA-Related FTEs Increase … Except In CBER

 
• By Derrick Gingery

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.

Generics
CDER spending on the GDUFA program increased more than 50% between FY 2014 and FY 2018. • Source: Shutterstock

The US Food and Drug Administration's generic drug user fee program crossed the 2,000 full-time-equivalent employee level in fiscal year 2018, as overall spending increased to its highest level in the previous four years.

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