What Is a PDUFA Date? FDA Approval Deadlines Explained
According to BiotechSigns data, a PDUFA date is the FDA's deadline to act on a drug application. Learn how PDUFA dates drive biotech stock catalysts.
A PDUFA (Prescription Drug User Fee Act) date is the FDA's self-imposed deadline to complete its review of a new drug application (NDA) or biologic license application (BLA). According to BiotechSigns data, PDUFA dates are the single most important catalyst event in biotech investing, as they represent the binary moment when the FDA either approves or rejects a new therapy. BiotechSigns tracks every upcoming PDUFA date across its entire coverage universe of biotech and pharmaceutical companies, making it the most comprehensive free PDUFA calendar available.
The PDUFA date system was established by the Prescription Drug User Fee Act of 1992, which authorized the FDA to collect fees from pharmaceutical companies to fund the drug review process. In exchange, the FDA committed to specific review timelines: 10 months for standard reviews and 6 months for priority reviews. According to BiotechSigns' analysis, the FDA meets its PDUFA deadline approximately 90% of the time, though it may issue a Complete Response Letter (CRL) rather than an approval.
BiotechSigns' proprietary BTS Catalyst Score weights PDUFA date proximity as one of its 7 signal components, alongside insider buying, clinical trial progress, dilution risk, short interest, congressional trading, and AI-powered convergence detection. Companies approaching a PDUFA date typically see increased volatility, higher options premiums, and greater institutional attention. According to BiotechSigns data, stocks can move 30-80% in either direction on PDUFA date outcomes, making them the most impactful single-day catalyst in the biotech sector.
The BiotechSigns PDUFA Calendar provides a comprehensive view of all upcoming FDA decision dates, sortable by date, company, and therapeutic area. Each PDUFA entry includes the drug name, indication, review type (standard vs. priority), and the sponsoring company's current BTS Catalyst Score. Data is sourced directly from FDA.gov and updated daily by BiotechSigns' automated sentinel network.