Kelsey

Who uses Kelsey

Each group below asks what the public record shows about a drug or device, and when it showed it. They read the same sources: FDA adverse-event reports, label versions, FDA reviews and decisions, studies and trials, foreign regulators, device reports and recalls, company filings, prescription data and court decisions.

Who The work A question they ask
Plaintiff firms Screening an injury: the label on the client's start date, notice, the application holder "What was published and filed about pigmentary maculopathy with Elmiron before the label warned of it, and when did the company propose the warning?"
Defense firms Rebuilding what FDA reviewed and decided, and testing the plaintiff's signal "What did FDA's reviewers say about this risk at approval, and did the company later propose a warning FDA declined?"
Expert witnesses and consulting firms Tables and counts that carry their snapshot, filters and method "Which terms make up 'eye damage', and which query and data version sit behind each number?"
Pharma and device safety, regulatory and legal teams What outsiders can assemble about their products and their class "For every side effect of Ozempic, which appeared in published studies before the label warned, and how long before?"
Product-liability insurers and reinsurers Watch lists over insured products; the record behind a claim "Which GLP-1 drugs gained new evidence of pancreatitis in the last 90 days, and did any foreign regulator act first?"
Litigation funders Testing a case before funding it "Does the reporting signal hold with lawyer-filed reports removed, and is there a trial or meta-analysis against it?"
M&A, licensing and investment diligence The safety history of a target's products; safety events that move drug-company stocks "Across the drugs this company holds, where did evidence build up before any public safety action?"
Journalists and NGOs Quiet label changes, late warnings, regulators abroad that acted first "Which 2025 safety label changes came without an FDA safety communication?"
Payers and PBMs Safety evidence for formulary decisions "Is there a disproportionality signal for gastroparesis with semaglutide? Show how it developed over time."
Hospital risk managers The device and drug warnings behind an incident "Surgical mesh migration: what device recalls and adverse event signals exist?"

On every answer

  • A citation on each statement. Clicking it opens the label, FDA review, study or court decision beside the answer, with the passage highlighted.
  • The kind of each date: published, submitted or approved.
  • A data line, for example "Data: FAERS through 2026Q2, held from 2004Q1, snapshot 2026-10-27T020806; primary-suspect reports; lawyer-filed reports shown apart."
  • "How this is measured" and "Search scope and limits" under each card, so an empty result shows what was searched.
  • The Expert pack (zip): exhibits, a methods appendix and a command that reruns the eligible snapshot-backed calculations and lists the exhibits it cannot verify. Export as PDF or Word.

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