The New FDA Draft Guidance – Now we HAVE to monitor, collect, analyze, alert and archive social media

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According to the new FDA Guidance on Postmarketing Submissions, organizations are responsible for reporting on comments made by employees and agents on social media sites about the organization’s products. Agent = “anyone acting on behalf of the firm.” It’s great that the industry does not have to report on “promotional” comments made by non-agent users,… Read more »

FDA Enforcement Trends In Social Media

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In September, the Food and Drug Law Institute held their annual Advertising & Promotion Meeting.Slides from the Social Media panel are available for download on the FDLI website. The slides have some excellent, though-provoking content, and are worth reviewing. Download Slides: http://www.fdli.org/docs/default-document-library/2013social-media-.pdf?sfvrsn=0 According to the presentation, the FDA warning letter themes focused on the following: “• … Read more »