Question 1

What is a PDUFA date?

Accepted Answer

A PDUFA date is the target action date by which the FDA must decide on a new drug application. It is set when the FDA accepts the BLA or NDA filing, calculated from the user-fee timeline (10 months for standard review, 6 months for priority review).

Question 2

How accurate is this calendar?

Accepted Answer

Dates are sourced from FDA briefing documents, sponsor 8-K filings, and quarterly earnings calls. Where the FDA has not publicly disclosed the date, we use the sponsor's most recent guidance, flagged accordingly.

Question 3

Can the FDA miss a PDUFA date?

Accepted Answer

Yes — the FDA can extend a PDUFA date by up to three months ("major amendment" extension) or request a Complete Response Letter (CRL) instead of approving by the date.

PDUFA Date Calendar