PDUFA
Medical abbreviation · Medical Research
| Stands for | Prescription Drug User Fee Act |
|---|---|
| Categories | Medical |
PDUFA stands for Prescription Drug User Fee Act, a medical research abbreviation.
US law first passed in 1992 that lets the FDA collect fees from drug companies to fund the review of new drug and biologic applications, in exchange for commitments to review timelines. It is reauthorized every five years.
Example: PDUFA date set for March 14; the market awaits the FDA decision.
Usage notes
The "PDUFA date" is the target date for an FDA decision, generally 10 months for standard review and 6 months for priority review after the application is accepted. The program sharply reduced review times compared with the 1980s. Pronounced "pa-DOO-fa".
Related abbreviations
More medical research abbreviations
- NS – Not significant (statistically)
- ODD – Orphan drug designation
- OHRP – Office for Human Research Protections
- OR – Odds ratio
- PBO – Placebo
- PCORI – Patient-Centered Outcomes Research Institute
- PI – Principal investigator
- PICO – Population, Intervention, Comparison, Outcome
- PMA – Premarket approval
- PMID – PubMed identifier
- PP – Per-protocol (analysis)
- PPV – Positive predictive value
See all 94 medical research abbreviations →
This entry is for general education and is not medical advice. Abbreviation use varies between institutions; always confirm in context.