FDA Decisions is a Tracker: a record of events from public sources, each with a date, a company and a source link. It is at app.palanor.com/trackers/fda. In your organization, members reach it through My Tracker, the Trackers row in the menu (app.palanor.com/<your organization>/trackers): its feed reads this tracker through your organization's scope, and every public tracker is listed below the feed. It opens on the upcoming PDUFA dates, soonest first.
What is in it
- PDUFA dates. The FDA's goal date for acting on an application, as the company itself stated it in an earnings call, an earnings release or a 10-Q. FDA does not publish pending applications or their dates, so a date is here only when the company said it. A date given as a month or a quarter is shown as that period, never as a day.
- Approvals and new indications. Every original NDA or BLA approval, and every efficacy supplement (a new indication), in Drugs@FDA from 2015. Novel marks the new molecular entities and new therapeutic biologics on FDA's own novel approvals list. Drugs@FDA lists an application under its current holder, which can differ from the company that won the approval.
- Complete response letters. The letters FDA sends when it cannot approve an application in its current form, as FDA publishes them on openFDA (it began in 2025). Later approved means FDA lists the application as approved after the letter.
Status
A PDUFA date is Upcoming while its window has not ended and no later company document reports an outcome; Decided once a later call, release or 10-Q reports approval, a complete response letter or a withdrawal; Date passed when the window ended with nothing on file. An outcome counts only when the company reports it as done: wording such as "if approved" or "we expect approval" is never read as an approval.
Coverage
PDUFA dates come from the companies Palanor tracks (Russell 1000 and S&P MidCap 400), so most small biotechs are not covered. Dates stated only on licensed earnings-call transcripts are shown to signed-in users and never leave Palanor through the API. Nothing here estimates the chance of an approval.
The decision-date rule
Under the table, A PDUFA date within 30 days sets an alert for any company; on a company's Dossier, Alert 30 days before a PDUFA date sets it for that company. It is read once a day and each date alerts once, when it comes inside your window.
Follow and alerts
Follow on a row watches that company; Follow this view watches the filters you have set. The rules under the table are shortcuts to the Alerts center, where you can change the numbers. A row counts when it first loads and only if it is dated within 45 days of that, so older filings loaded later never flood you. Alerts arrive in the bell, by email or on your phone, inside your quiet hours and limits. See [Alerts center](/help/modules/alerts-center).
Companies, downloads and the API
Rows are linked to companies by SEC CIK, or by name under the company graph's conservative rules; a linked subsidiary's rows also reach its listed parent. A company's Dossier has a Trackers panel with its rows. Rows download as CSV with a Pro or Enterprise API key or a full seat on Palanor Enterprise, and come through the API at /v1/trackers/fda and the MCP tool palanor_tracker (rows whose source allows redistribution only). Numen can read the tracker too.