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Home » US FDA’s new misinformation draft guidance revisits 2014 version
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US FDA’s new misinformation draft guidance revisits 2014 version

July 8, 2024
By Mark McCarty
Bob Califf, commissioner of the U.S. FDA, has been laser-focused on misinformation recently, and the agency reissued a 2014 draft guidance that describes an enforcement policy about third-party communications about a drug or device. The draft appears to sidestep at least one major problem with the 2014 edition, but seems to suggest that manufacturers should consider addressing misinformation about an entire class of products.
BioWorld MedTech Regulatory U.S. FDA

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