How Math Errors May Have Cost US FDA Millions In PDUFA Fees

A lack of process documentation was part of the reason the FDA forgot to account for fee refunds in its estimates of incoming applications for two fiscal years, a mistake that likely cost the agency millions in revenue.

accounting
Submission volatility remains a problem for PDUFA fee calculations. • Source: Shutterstock

More from User Fees

More from Pathways & Standards