Sources
Built on the public record.
Everything known about a drug or device, connected and placed in time. Refreshed every night; anything missing is fetched live from PubMed, DailyMed and ClinicalTrials.gov.
In plain words
What Kelsey connects.
Every fact is dated, sourced and connected.
FDA adverse-event reports
21 million reports of side effects sent to FDA.
The full label history
Every version of a drug’s label, and what the warning said in each.
FDA reviews and decisions
FDA’s own reviews and decisions.
Studies and trials
Published studies, with PubMed searched live, and clinical trial results.
Regulators abroad
Europe, the UK, Canada, Switzerland and others.
Device reports and recalls
Reports of device problems, and recalls.
Prescription data
How widely a drug is prescribed.
Company filings
Filings the company made with the SEC.
Court decisions and statutes
Rulings and the laws behind them.
Inventory
The datasets by name.
Dataset names, for readers who want to check them.
| Family | Datasets | What it adds |
|---|---|---|
| FDA adverse-event reports | FAERS | FDA’s database of reported side effects. |
| Labels and approvals | DailyMed label history; Drugs@FDA; Orange Book | Each label version, who holds the application, and the approved products. |
| FDA reviews and actions | Safety label changes; safety communications; warning letters; advisory committees; approval reviews; citizen petitions; guidance | What FDA reviewed, said and decided. |
| Regulations and statutes | eCFR; US Code; Federal Register | The rules as they read on a given date. |
| Studies and trials | PubMed (searched live for each drug); ClinicalTrials.gov | Published studies and trial results. |
| Regulators abroad | EMA; MHRA; Health Canada; Swissmedic; Canada Vigilance | Warnings and reports from outside the US. |
| Devices | MAUDE; 510(k); PMA; recalls; GUDID | Device reports, clearances, approvals and recalls. |
| Company and prescribing | SEC filings; Medicare Part D; Medicaid | The company behind a product, and how widely it is prescribed. |
| Courts | Court opinions; state product-liability statutes | The rulings and the laws behind them. |
| Names | RxNorm; ATC; links between them | One drug under every brand, generic and company name, and side effects matched across medical vocabularies. |
Method
How Kelsey handles the record
- Every fact is dated, sourced and connected.
- It knows what was knowable on any date.
- It never claims what the record cannot prove.
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