Submission & Approval

Prescription Drug User Fee Act(PDUFA)

US legislation that allows the FDA to collect fees from drug manufacturers to fund the new drug approval process.

Usage Examples

The PDUFA date for the NDA is September 15.
FDA met 95% of PDUFA goals last fiscal year.
PDUFA VII introduced new rare disease commitments.

What is PDUFA?

The Prescription Drug User Fee Act (PDUFA) was enacted in 1992 to allow FDA to collect fees from pharmaceutical companies submitting NDAs and BLAs. These fees fund FDA review staff and help meet statutory review timelines.

PDUFA establishes performance goals for FDA review times, including 10-month standard reviews and 6-month priority reviews. The Act is reauthorized every five years, with each iteration (PDUFA I through VII) introducing new commitments and goals.

User fees include application fees, establishment fees, and product fees. The FDA publishes PDUFA date letters indicating the target action date for each submission.

Regulatory Context

This term appears most often in submission & approval workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside PDUFA, 21 CFR 314.

FDAICHEMA

When This Matters

The PDUFA date for the NDA is September 15.
FDA met 95% of PDUFA goals last fiscal year.
PDUFA VII introduced new rare disease commitments.

Common Mistakes

Treating submission readiness as a formatting-only check without lifecycle validation.
Using outdated guidance references across modules and summaries.
Missing cross-functional review between RA, CMC, and quality before submission.

Related Regulations

PDUFA21 CFR 314

Frequently Asked Questions

The PDUFA date is FDA's target date for completing review of a drug application. It's calculated based on the application filing date and whether it's a standard (10-month) or priority (6-month) review.

PDUFA fees vary annually and include application fees (over $3 million for 2024), establishment fees, and product fees. Small businesses and orphan drugs may qualify for waivers or reductions.