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  • Clock Starts Ticking on Issuance of FDA's Social Media Guidance

    The end is near-for marketing professionals waiting for the US Food and Drug Administration (FDA) to issue its long-discussed and long-delayed guidance on the appropriate use of social media for marketing healthcare products, that is. Buried deep within the FDA Safety and Innovation Act (FDASIA), signed into law on 9 July 2012 by President Barack Obama, is a provision mandating that FDA issue social media guidance no later than 9 July 2014. "Not later than 2 years aft...
  • Watermelon and Web-links Form Basis of Drug Promotion Complaint Against Swedish Company

    • 25 June 2012
    [ Editor's note: an earlier version of this story indicated the website was run by Quintiles. Quintiles is only the marketing representative of Swedish Orphan Biovitrum AB in the US, and was not responsible for the website. ] The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a warning letter to Swedish Orphan Biovitrum AB for allegedly making misleading claims regarding the safety and efficacy of Kepivance (palifermin) on a w...
  • Warning Letter Analysis: Device Companies Hit for Marketing, Social Media Problems

    • 13 June 2012
    Alleged marketing deficiencies were the subject of nearly identical warning letters sent to two separate manufacturers of hypoerthermic medical devices, both of whom were accused of using online advertisements to promote their respective devices for conditions not cleared or approved by the US Food and Drug Administration (FDA). ThermaSolutions Incorporated (Medical Device)  [See: 22 June 2012 Update] In its 7 May warning letter to Minnesota-based medical device ...
  • DHHS Looks to Social Media for Warning Signals

    • 22 March 2012
    A new US Department of Health and Human Services (DHHS) initiative is looking to use social media tools-specifically the micro-blogging website Twitter-to provide the agency with advanced signals to help identify public health emergencies. In a 20 March press release, DHHS said it is looking for developers to create tools that look at real-time data on public health issues, with a particular focus on illnesses. The agency hopes to develop a tool that will be "useful as ...