PDUFA stands for the Prescription Drug User Fee Act, which was first enacted in 1992. Under PDUFA, the U.S. Food and Drug Administration (FDA) is authorized to collect fees from pharmaceutical companies submitting new drug applications (NDAs) or biologics license applications (BLAs). The purpose of these fees is to provide the FDA with additional resources to expedite the drug approval process, ultimately allowing faster access to new therapies for patients.
The PDUFA date is a specific target date by which the FDA aims to complete its review of a new drug application (NDA) or a biologics license application (BLA). This date is typically set upon the receipt of the application and is usually 10 months from the filing of the application for standard review or 6 months for priority review.
On the PDUFA date, the FDA may:
In summary, PDUFA and the PDUFA date are integral parts of the drug approval process in the United States, aimed at ensuring timely access to new and effective therapies while maintaining rigorous standards of safety and efficacy.