Off-Label Use Discussions Should Stay Off-line, FDA Draft Guidance Says

 
• By Brenda Sandburg

FDA advises companies to respond to unsolicited requests for off-label information in one-on-one dialogue; the agency also requests public comments on its policies regarding off-label communications in response to an industry citizen petition.

FDA is advising drug companies not to engage in online discussions about off-label uses of their products but to instead direct individuals posing questions to contact them directly.

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