Kelsey

31 public sources

A nightly pipeline checks for updates; refresh schedules and coverage vary by source. Anything missing from the stored data is fetched live from PubMed, DailyMed and ClinicalTrials.gov.

Datasets by family
FamilyDatasetsWhat it addsCoverage
FDA adverse-event reportsFAERSFDA’s database of reported side effects.From 2004, with its predecessor AERS
Labels and approvalsDailyMed label history; Drugs@FDA; Orange BookEach label version, who holds the application, and the approved products.Orange Book editions from 1985
FDA reviews and actionsSafety label changes; safety communications; warning letters; advisory committees; approval reviews; citizen petitions; guidanceWhat FDA reviewed, said and decided.
Regulations and statuteseCFR; US Code; Federal RegisterThe rules as they read on a given date: 21 CFR by date (annual editions before December 2016), the current US Code.
Studies and trialsPubMed (searched live for each drug); ClinicalTrials.govPublished studies and trial results.
Regulators abroadEMA; MHRA; Health Canada; Swissmedic; Canada VigilanceWarnings and reports from outside the US.
DevicesMAUDE; 510(k); PMA; recalls; GUDIDDevice reports, clearances, approvals and recalls.
Company and prescribingSEC filings; Medicare Part D; MedicaidThe company behind a product, and how widely it is prescribed.
CourtsCourt opinions; state product-liability statutesFederal and state court decisions; the current product-liability statutes of Texas, Michigan, New Jersey and Louisiana.
NamesRxNorm; ATC; links between themOne drug under every brand, generic and company name, and side effects matched across medical vocabularies.

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