PDUFA calendar methodology and coverage

Inclusion and scope

Initial coverage contains seven application-and-indication records selected for accessible primary evidence and future dates at the November 14, 2026 review. Selection is editorial; it is not based on expected approval, stock performance or investment merit.

The source hierarchy is FDA decision material when an action is published, then the sponsor’s dated SEC filing, earnings release or regulatory announcement. FDA’s PDUFA program page supplies general context, not the individual dates in this dataset.

Freshness and source checks

The public tables show the source publication date and this pilot’s review date. Retrieval timestamps and content hashes are saved in the maintenance evidence. Downloading a source does not automatically certify that an application remains pending.

The maintenance check archives public documents and tests for expected date text. Any missing token, failed fetch, changed content, new sponsor update or elapsed target requires human review. There is no claimed daily update schedule.

Maintenance rules

• Recheck selected sponsors’ latest disclosures weekly and before a target date; this is the intended operating cadence, not a completed automation claim.
• Use a new source for an actual date revision or outcome; keep prior observations.
• Keep the product, indication, jurisdiction and application type in the same record.
• Mark an overdue unreviewed target as needing review instead of inventing a result.
• Expand coverage only after retrieving and checking the original source.

Corrections and limits

Send the product, indication and a direct primary-source link through Synoptic contact for a correction. This calendar has no FDA affiliation. It is a research aid and does not provide medical advice or a prediction of a regulatory decision.