What Is a PDUFA Date?

PDUFA, first passed in 1992 and renewed every five years, lets the FDA collect fees from drug sponsors in exchange for review-time commitments. For a new molecular entity the standard goal is ten months after the FDA's 60-day filing review, so about twelve months after submission; a priority review, granted when a drug would be a significant improvement for a serious condition, cuts that to six months plus the same 60 days. Resubmissions after a complete response letter get shorter clocks: two or six months depending on how much new work the FDA must review.

The FDA does not publish PDUFA dates. Companies disclose them, usually in the press release announcing that the application was accepted for review, and they repeat them in every investor presentation until the decision.

• →A major amendment to the application, such as new clinical data or a new manufacturing site, lets the FDA extend the goal by three months. Companies announce these extensions, and the market treats them as a mild negative because they signal the FDA had questions.
• →An advisory committee meeting scheduled inside the review window does not change the date, but a meeting scheduled close to it usually means the decision will land on the last possible day.
• →Manufacturing inspections that cannot be completed, often at foreign plants, have delayed decisions past the goal without any change to the official date.
• →The FDA can act early. Approvals weeks ahead of the goal date are common for priority reviews and uncontroversial supplements.

There are two outcomes. Approval, announced by the company and posted by the FDA, with the approved label attached; the label's indication, warnings and any required post-marketing studies decide how good the approval is commercially. Or a complete response letter, which the FDA sends to the company and does not publish; the company summarises it in a press release and an 8-K, and the quality of that summary is a signal in itself. A letter that cites only manufacturing or labelling issues is a delay. One that asks for a new clinical trial is a rejection in all but name.

The stock usually moves before the day. Options prices, the advisory committee outcome, the FDA's track record on similar drugs and the company's own language in the weeks before all feed a market view, and the reaction on the day is to the surprise, not the decision. A widely expected approval can produce a flat or falling stock.

A known binary date is context for everything else that happens to the company before it. An insider buying two months ahead of a decision, an offering priced the week after an approval, an activist filing on a company with a pending decision: each reads differently with the date in view. InsiderWatch keeps a catalyst calendar of stated PDUFA and advisory committee dates for each verified company, built only from dates the company or the FDA has published, and attaches the pending date as context to alerts on that company. It never guesses a date and never treats the date itself as a signal in either direction.