PDUFA date

Under the Prescription Drug User Fee Act, companies pay a fee when they submit a new drug application or biologics license application, and in exchange the FDA commits to a target action date: ten months from the filing acceptance for a standard review, six months for a priority review. The agency announces the date to the company, which typically discloses it in an 8-K, and the date is what the industry calls the PDUFA date.

It is a target for FDA action, not a guarantee of approval or of timing. The agency can approve early, issue a complete response letter, or extend the date by three months if the company submits a major amendment. Advisory committee meetings, facility inspections and manufacturing questions all move it.

Financially it is a hard planning date. Commercial hiring, launch inventory, and market-access work all have to be committed months before the decision, which means spending against an outcome that has not happened. It also changes the accounting: pre-approval manufacturing is expensed as research and development until approval is probable, so the same batch can be an expense one quarter and inventory the next.