Consent decree
The vocabulary of getting a claim paid, of FDA enforcement, and of what on-label and off-label really mean.
What is Consent decree?
A court-ordered settlement between a company and the government, typically imposing operating conditions and independent oversight.
It is far heavier than a warning letter, and it is the instrument that stops a seller from operating as it did.
Related reading: FDA Warning Letters register
GLP Watchdog writes these definitions from FDA labels and peer-reviewed PubMed literature.
Other terms under Insurance and regulatory
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