Off-Label Questions, Online: FDA Explains How To Handle Them

FDA draft guidance weighs in on web communications, saying that firms must answer off-label-information questions privately, even if the questions arise in a public online forum.

If a patient poses a question about an off-label use of a product on a public online forum, it is OK for the product’s manufacturer to respond, but it should do so privately, and not within view of a broader online audience, FDA says.

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