PDUFA date

A PDUFA date is the target date by which the US Food and Drug Administration aims to act on a new drug application (NDA) or biologics license application (BLA), either by approving it or by issuing a complete response letter. The name comes from the Prescription Drug User Fee Act, under which drugmakers pay fees and the FDA commits to review timelines.

How it works

After an application is submitted, the FDA has 60 days to decide whether to accept it for review. If accepted, it sets the goal date:

If the sponsor submits a major amendment during review, the FDA can extend the goal date by three months. The FDA does not publish PDUFA dates itself; companies disclose them in press releases and SEC filings.

Why it matters for traders

For a single-product biotech, the PDUFA date is often the biggest binary event in the company's life. Things traders watch:

• Run-up and sell-the-news. Shares often climb into the date and can fall even on approval.
• Implied volatility. Options typically price a large move, then collapse after the decision.
• Early or late action. The FDA can act before the goal date, and occasionally misses it.
• Label details. Indication breadth, boxed warnings and REMS requirements shape the commercial outlook.

Example

A hypothetical biotech, Northwind Therapeutics (NWTX), submits an NDA for a new molecular entity on March 1 with priority review. Filing is accepted 60 days later, around April 30, and the six-month clock puts the PDUFA date around October 30, roughly eight months after submission.

FAQ

What happens on a PDUFA date?

The FDA either approves the application or issues a complete response letter. The company usually announces the outcome by press release, often after market close.

Can the FDA decide before the PDUFA date?

Yes. Early approvals happen, though most decisions arrive on or near the goal date.