Zdrowie i gospodarka · 18.06.2014
Draft Guidance for Industry on Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Internet/ Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices." This draft guidance responds to (among other things) stakeholder requests for specific guidance and describes FDA's current thinking on how manufacturers, packers, and distributors (firms) of prescription human and animal drugs (drugs) and medical devices for human use (devices), including biological products, should respond, if they choose to respond, to misinformation related to a firm's own FDA-approved or cleared products when that information is created or disseminated by independent third parties. This draft guidance updates and clarifies FDA's policies on the correction of misinformation created or disseminated by independent third parties on the Internet or through social media platforms, regardless of whether that misinformation appears on a firm's own forum or an independent third-party forum or Web site. The draft guidance represents FDA's current thinking on specific aspects of FDA's evolving consideration of social medi