# PDUFA date

> The target date by which the FDA aims to approve or reject a new drug or biologic application under the Prescription Drug User Fee Act.

Source: https://www.quantisnow.com/glossary/pdufa-date
Topic: Glossary / Biotech and FDA
Also known as: PDUFA goal date, FDA action date, target action date
Last updated: 2026-10-27

A PDUFA date is the target date by which the US Food and Drug Administration aims to act on a [new drug application (NDA)](https://www.quantisnow.com/glossary/nda) or [biologics license application (BLA)](https://www.quantisnow.com/glossary/bla), either by approving it or by issuing a [complete response letter](https://www.quantisnow.com/glossary/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:

| Review type | Goal for new molecular entities | Goal for other applications |
| --- | --- | --- |
| Standard | 10 months after the 60-day filing date (about 12 months from submission) | 10 months from receipt |
| [Priority](https://www.quantisnow.com/glossary/priority-review) | 6 months after the filing date (about 8 months from submission) | 6 months from receipt |

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](https://www.quantisnow.com/glossary/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.

## Related terms

- [Complete response letter (CRL)](https://www.quantisnow.com/glossary/complete-response-letter.md): A letter from the FDA stating it cannot approve a drug or biologic application in its current form and explaining the deficiencies to fix.
- [New Drug Application (NDA)](https://www.quantisnow.com/glossary/nda.md): The formal application a drugmaker submits to the FDA requesting approval to market a new small-molecule drug in the United States.
- [Biologics License Application (BLA)](https://www.quantisnow.com/glossary/bla.md): The application a company submits to the FDA to market a biologic, such as an antibody, vaccine or gene therapy, in the United States.
- [Priority review](https://www.quantisnow.com/glossary/priority-review.md): An FDA designation that shortens the review goal for a drug application to 6 months instead of the standard 10 months.
- [FDA advisory committee (AdCom)](https://www.quantisnow.com/glossary/advisory-committee.md): A panel of outside experts that reviews a drug or device application in a public meeting and votes on questions such as whether benefits outweigh risks.

## On Quantisnow

- [PDUFA dates explained](https://www.quantisnow.com/guides/pdufa-dates-explained)
- [Live feed: FDA Approvals](https://www.quantisnow.com/news/fda)
- [Latest FDA approvals and announcements](https://www.quantisnow.com/top/fda-approvals)
- [Latest PDUFA date announcements](https://www.quantisnow.com/top/pdufa-dates)