A PDUFA date, or goal date, is FDA's target date for acting on a drug or biologic application under the Prescription Drug User Fee Act. A complete response letter (CRL) is also an action. Launch sequences, licensing milestones, and first payer meetings are often dated from the goal date a sponsor disclosed. Plan for each outcome the date can bring, and read the public documents that already bear on which one it will be.
For launch, business development, and market access teams planning around an FDA action date.
FDA does not publish the goal date of an application under review. The date in a plan comes from the sponsor or its partner: a press release, a 10-Q, or an 8-K. Each registered goal-date record below names the filing its date was taken from; for FF-007 that is the licensor's quarterly report, not the applicant's.
Under the PDUFA goals for fiscal years 2023 to 2027, FDA aims to review and act on 90 percent of applications within the goal period: ten months for a standard review and six for a priority review. The clock starts at the 60-day filing date for a new molecular entity or an original biologic, and at receipt for other original applications and for efficacy supplements. The goal is to act, and a CRL meets it as fully as an approval does.
The approved indication can be narrower than the one sought, by population, line of therapy, or setting of use. Tie promotional review, the payer dossier, and field planning to the approved label rather than the proposed one.
A CRL means the application is not approved in its present form. A resubmission is classed by what it contains, and FDA's goal is to act on a Class 1 resubmission within two months and a Class 2 within six. FF-008 is a Class 2 resubmission after a CRL that found the evidence of effectiveness insufficient.
A major amendment submitted during review, such as a new clinical study report or a major reanalysis, may extend the goal date by three months, and the goals allow one extension per review cycle. FF-008 and FF-013 each had their goal date extended this way before registration; both records froze the extended date.
FDA can let a goal date pass and act later, and the sponsor can withdraw the application before it. Where a plan or a contract is written as approval by a date, a later approval is a different outcome from an on-time one, and the registered records score it as having occurred after the deadline.
Read the sponsor's 10-Q, 10-K, and 8-K filings as well as its press releases. Each item below comes from a sponsor's filing that a registered record found before its evidence cutoff and cites.
Each row is a registered estimate that FDA approves by the goal date the sponsor disclosed, frozen before the date. Beside it is the record's calendar-cycle baseline, a model that knows only the clock. A baseline is a competing estimate frozen at the same cutoff, not an observed result. The record page carries the proposition, the sources, and the rule an adjudicator will read.
FDA action by goal date: 14 registered · 14 unresolved · 0 resolved. Registry snapshot 2026-10-06.
Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved.
A sponsor's announcement is its statement; the approval letter and the label are FDA's record. Drugs@FDA lists approvals of drugs and of the biologics CDER reviews. The Purple Book lists licensed biologics, including the cell and gene therapies CBER reviews. Each registered record names the database it will be read from and a read date after the goal date, because the public databases can trail the letter.
For a supplement, identify the approval by what the new label says: the trial, population, or setting your plan assumed. The supplement number is not public until FDA acts, and a database's category for a supplement can mislead; FF-009's record explains one that did.
What each team changes if the decision comes earlier or later than planned.
Which decision matters to your team, and by what date? Include the population and the plan it would inform.
Start with one claim