Close-out letter
The vocabulary of getting a claim paid, of FDA enforcement, and of what on-label and off-label really mean.
What is Close-out letter?
FDA's confirmation that a company has corrected what a warning letter cited.
We do not track close-outs, so a letter in this register tells you only that FDA said something. It does not tell you how the company answered or whether the matter ended there. Ask the company; they will usually tell you, and how they answer is informative.
Related reading: FDA Warning Letters register
GLP Watchdog writes these definitions from FDA labels and peer-reviewed PubMed literature.
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