The public record on any drug or device, in one cited answer.
Safety reports, label history, FDA decisions, studies and case law, searched together, with every statement cited to the original document.
The passage behind the answer.
A real question, the kind a trial team asks: was the harm knowable before the label warned?
WARNINGS
Retinal Pigmentary Changes Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use.
Clicking a citation opens the original label text beside the answer, with the supporting passage highlighted. The answer also lays the same question out as a dated chronology, from the 2018 study to the 2020 label change.
Three investigations, one tool.
Kelsey is a broad research tool, not a single feature.
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A pattern across a drug class
Ask“Which GLP-1 drugs gained new evidence of pancreatitis in the last 90 days, and did any foreign regulator act first?”
What comes backA watch list, with foreign warnings and their dates.
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What FDA reviewed and decided
Ask“What did FDA’s reviewers say about this risk at approval, and did the company later propose a warning FDA declined?”
What comes backThe reviewers’ passages, the company’s submissions and FDA’s response, quoted and dated.
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The law around it
Ask“Which rulings on expert testimony accepted or rejected statistical analysis of FDA adverse-event reports?”
What comes backThe rulings, in the same answer as the evidence.
The public record, connected and placed in time.
Every fact is dated, sourced and connected. Refreshed every night.
21 millionFDA adverse-event reports, connected to everything else that is public about the same drug or device.
- The full label history
- FDA reviews and decisions
- Published studies and clinical trials
- Regulators abroad
- Device reports and recalls
- Prescription data
- Company filings
- Court decisions and statutes
What the reader can check.
Everything a lawyer or expert needs to check is on the screen.
Litigation first.
US drug and device litigation firms, on both sides, and the experts who work with them. They need to know what was known about a drug’s or device’s risks, and when.
The same cited record serves pharma and device legal and safety teams, product-liability insurers, litigation funders and due-diligence teams.
Working product. Test links upon request.
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