FDA Calendar - PDUFA Dates & AdCom Meetings

Frequently asked

Common questions about PDUFA dates and FDA review timelines

What is a PDUFA date and when does the FDA decide?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to decide on a drug application (NDA or BLA). Standard Review is 10 months from submission acceptance; Priority Review is 6 months. The FDA aims to issue a decision — Approval, Complete Response Letter (CRL), or extension — by this date. TheraRadar currently tracks 63 upcoming PDUFAs.

What happens if the FDA misses the PDUFA date?

The FDA may extend the PDUFA date by 3 months (a "major amendment extension") when the sponsor submits significant new information late in the review cycle. Less commonly, the FDA issues a Complete Response Letter (CRL) outlining deficiencies — the sponsor must resubmit to restart the clock. Approximately 10–15% of applications receive CRLs rather than approvals on the original PDUFA date.

What's the difference between a PDUFA date and an AdCom meeting?

An Advisory Committee (AdCom) meeting is a panel of outside experts that reviews a drug application and votes on whether the FDA should approve it. AdComs are not always required — they happen for complex, controversial, or first-in-class drugs. The AdCom vote is non-binding but the FDA usually follows it. AdComs typically occur 2–4 months before the PDUFA date, making them earlier catalysts than the PDUFA decision itself.

What's the difference between Priority Review and Standard Review?

Priority Review (6-month PDUFA) is granted when a drug offers significant improvement over existing options for a serious condition — e.g., first-in-class mechanisms, breakthrough therapies, orphan drugs. Standard Review (10-month PDUFA) applies to drugs that primarily duplicate existing therapies. Priority Review also waives the user fee for the sponsor. Roughly 25–35% of NMEs receive Priority Review.

Why are some recent PDUFA dates missing from this calendar?

TheraRadar's PDUFA calendar is built primarily from public SEC 8-K filings where companies disclose FDA acceptance of their drug applications. This misses: (1) private companies not subject to SEC filing, (2) foreign-listed sponsors that file 6-Ks rather than 8-Ks, (3) supplementary BLAs (sBLAs) that companies sometimes don't 8-K, and (4) sponsors that disclose only via press release. We supplement SEC data with manually curated entries from press releases and earnings transcripts. If you spot a missing PDUFA, use the "Report wrong date" button above.

How often is the PDUFA calendar updated?

The PDUFA calendar refreshes weekly — TheraRadar pulls the latest SEC 8-K filings and matches them against the manual override list. Past PDUFA dates whose outcomes are known are also marked. Last updated: May 20, 2026.