Methodology
How Assyro sources and validates PDUFA dates
Every event on this page is sourced from FDA primary records, including the FDA’s drug approval pages, public dataset feeds, and current prescribing information labels, supplemented by sponsor SEC filings and press releases when they reference a PDUFA target action date. Each record carries a source confidence score derived from the original document type and freshness, and the underlying URLs are linked from each event’s quick-view modal so any claim on this page is auditable back to its source.
A nightly synchronization process detects changes to existing PDUFA dates and FDA decisions, versioning each event so historical records remain inspectable. When two sources disagree, FDA-authored documents take precedence over sponsor disclosures. Records flagged Unknown reflect events where source confidence is below threshold and human verification is pending. No estimated or speculative dates are published.
