Lexology September 6, 2024
On July 8, 2024, the Food and Drug Administration (FDA) released updated draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” that replaces similar guidance from 2014 on the same topic, “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.” The new guidance document sets out FDA’s enforcement policy for internet-based communications used to address internet-based misinformation about or related to a company’s approved or cleared medical product when that misinformation is created or disseminated by an independent third party.
The draft guidance applies when a company voluntarily responds to internet-based misinformation and explicitly excludes TV and radio advertisements, even when disseminated by firms via the internet (such as during streamed TV...
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