What powers pdufa.bio, how often it updates, and what it does and doesn't cover. We publish our own metadata because a data source of record should.
Data source register
Every dataset behind this site, what it's licensed under, and whether we're allowed to redistribute it. We publish this because an accuracy brand that won't show its supply chain isn't one.
Source
What we use it for
Licence
Redistribute?
FDA (openFDA, press, PDUFA reports)
Decisions, approvals, CRLs
Public domain
Yes
SEC EDGAR
8-Ks, PDUFA dates, cash runway
Public domain
Yes
ClinicalTrials.gov
Trial design, NCT IDs, readout windows
Public domain
Yes
Federal Register
AdComm meeting notices
Public domain
Yes
FINRA
Short interest at catalyst
Public domain
Yes
ChEMBL
Drug modality & mechanism
Open (CC BY-SA)
Yes, with attribution
Market data vendors
Daily prices, volume
Paid licence
Derived statistics only: never raw
What we deliberately do not use. No competitor's calendar is republished here, not BioPharmaCatalyst, not any other. We use one privately as a QA yardstick to check our own coverage, and none of it ever reaches this site, the API, or the sitemap; that rule is enforced by a test that blocks deploys. We also removed a licensed DrugBank database from our repository rather than risk using it commercially.
Primary sources
FDA decision dates & outcomesFDA / company 8-K, 6-K, press releases; openFDA
Trial status & readout timingClinicalTrials.gov API v2
Cash runway & filingsSEC EDGAR (10-Q/10-K/8-K)
Update cadence
FDA decision dates, catalyst data and registry status are checked against primary FDA / SEC / ClinicalTrials.gov filings on an ongoing basis. Each catalyst carries a source type and a confidence level.
Coverage & honesty
We track upcoming U.S. FDA decisions (PDUFA) and a growing set of clinical readouts; the historic archive is being expanded and source-verified in batches: outcomes not yet verified are labeled price-only, not 'verified.' We are not affiliated with the FDA, we do not estimate per-drug approval probabilities, and every date can slip: verify against the primary filing. See our methodology.