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Tag Archives: warning letters
FDA Warning Letters vs Untitled Letters
History is a vast early warning system. – Norman Cousins The Drug and Device Law blog recently published two short posts on FDA warning letters. The first post mistakenly described an untitled letter, referenced in a lawsuit, as a warning … Continue reading
Posted in FDA
Tagged enforcement action, FDA, regulations, untitled letters, warning letters
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First Example of Proposed DTC Rules in Effect?
No one can possibly know what is about to happen: it is happening, each time, for the first time, for the only time. – James Arthur Baldwin Hey, remember those proposed DTC advertising rules that the FDA published recently? Well, … Continue reading
Posted in FDA, Industry News
Tagged advertising, DDMAC, direct to consumer, DTC, FDA, guidance, warning letters
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