Insurance and regulatory

Consent decree

The vocabulary of getting a claim paid, of FDA enforcement, and of what on-label and off-label really mean.

Definition

A court-ordered settlement between a company and the government, typically imposing operating conditions and independent oversight. Far heavier than a warning letter: this is the instrument that actually stops a seller operating as it did.

The warning-letter register

GLP Watchdog writes these definitions from FDA labels and peer-reviewed PubMed literature. Not one of them is an AI-generated summary.

Other terms under Insurance and regulatory

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