PDUFA

Also known as: Prescription Drug User Fee Act

The US law that authorises FDA user fees from sponsors in exchange for performance commitments.

Definition

The Prescription Drug User Fee Act (PDUFA), reauthorised every 5 years, allows the FDA to collect user fees from drug sponsors in exchange for binding review-time commitments — most prominently the 10-month (standard) and 6-month (priority) target action dates. PDUFA fees fund a significant portion of FDA drug review staffing.

See also

• PDUFA date — The FDA target action date for an NDA or BLA, set under the Prescription Drug User Fee Act.
• Priority review — FDA designation that shortens NDA/BLA review to 6 months for drugs offering significant improvement.

Other regulatory terms

• NDA
• BLA
• PDUFA date
• Priority review
• Breakthrough Therapy
• Accelerated approval