As Pandemic Delays Reduce PDUFA Revenues, US FDA Slows Fee-Related Spending

Agency cites “unexpected and large drop in collections” in slashing user-fee-setting contract.

Dominoes falling on gray background
Signs have emerged that the pandemic slowed the pace of new drug applications. • Source: Shutterstock

A substantial drop in prescription drug user fee revenue last year, suspected to have been caused by delayed application submissions, forced the US Food and Drug Administration to scale back user-fee-related capacity planning.

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