About Kelsey
What an answer from Kelsey holds, where the product stands, and the FDA medical officer it is named after.
What an answer holds
You ask about a drug or device in plain English, and each statement in the answer cites the FAERS report, label version, FDA review, study, foreign regulator's action or court decision it rests on; a click opens that document beside the answer with the passage highlighted. Each date carries its type (published, submitted or approved), and each figure (report counts, PRR, ROR, IC and EBGM with their intervals) comes from a stored query run on a named data snapshot, with lawyer-filed reports counted separately. The Expert pack exports the exhibits, a methods appendix and a command that reruns the eligible snapshot-backed calculations and lists the exhibits it cannot verify.
Where it stands
Working product. Test links on request: write to hello@kelsey.legal with your firm or company, your role and a public drug or device you want to see.
The name
Frances Oldham Kelsey joined FDA as a medical officer in 1960, and one of her first assignments was the application for thalidomide, already sold in dozens of countries; despite constant pressure from the company, she refused to approve it because the evidence was inadequate.[1] The US application was for the brand Kevadon, and her review prevented its approval.[2] FDA later approved thalidomide, as Thalomid, in 1998 for a different use; the label describes data on erythema nodosum leprosum.[3]
Company
Kelsey is operated by Original Media BV, a company in Kalmthout, Belgium, until its US company is formed.
Kelsey is independent. It is not affiliated with the U.S. Food and Drug Administration.
Contact
hello@kelsey.legal
Sources
- FDA, Frances Oldham Kelsey: Medical reviewer famous for averting a public health tragedy. https://www.fda.gov/about-fda/fda-history-exhibits/frances-oldham-kelsey-medical-reviewer-famous-averting-public-health-tragedy
- FDA, A Brief History of the Center for Drug Evaluation and Research. https://www.fda.gov/about-fda/fda-history-exhibits/brief-history-center-drug-evaluation-and-research
- FDA, THALOMID (thalidomide) capsules prescribing information: "Initial U.S. Approval: 1998"; section 14.2 describes the Erythema Nodosum Leprosum (ENL) data. https://www.accessdata.fda.gov/spl/data/79edac72-7cef-4dad-a5b5-debfb449808d/79edac72-7cef-4dad-a5b5-debfb449808d.xml