The Prescription Drug User Fee Act, first passed in 1992, allows the FDA to collect fees from companies that submit applications, in return for meeting agreed review timelines. The law is reauthorized every five years. The current version, PDUFA VII, covers fiscal years 2023 to 2027.
Under these goals, the FDA aims to act on a standard application within ten months and on a priority application within six months. For new molecular entities and original biologics applications, the clock starts at the 60-day filing date, so the goal falls roughly twelve or eight months after submission. A major amendment to an application during review can extend the goal date by three months.
By the PDUFA date, the FDA normally either approves the application or issues a complete response letter explaining why it cannot approve it in its current form. Decisions sometimes come earlier than the goal date.
The FDA does not usually publish PDUFA dates itself. Companies typically disclose them when an application is accepted for review, which is why they appear in press releases and investor materials, and why they are a fixture of every pharma catalyst calendar.