Category Archives: FDA

Making the Most of Social Media (Within FDA’s New Guidelines)

By Ken Ribotsky. Pharmaceutical companies have begun using social media for business needs and promotion, yet have been hesitant to become too engaged since the FDA’s stance on social media activity remained unclear. But now that we know the FDA’s specific guidelines for pharma companies’ actions online, it’s time for brands to consider diving into […]
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FDA Warning to GSK Biologicals

FDA issued a warning letter to GlaxoSmithKline Biologicals (GSK), North America on June 12, 2014 for deviations from cCGMP requirements found during an inspection from Mar. 31 to Apr. 9, 2014 of its influenza vaccine manufacturing facility in Quebec. GSK is making progress in addressing FDA’s concerns and is working to meet supply commitments, the […]
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New Social Media Guidelines: What FDA Says, and What It Means

By Simon Beins is Associate Director, Strategy, Heartbeat Ideas & Heartbeat West. Earlier this year, FDA promised three sets of guidelines to clarify using social media for pharma marketing. Last week it delivered two of them The first, Internet/Social Media Platforms with Character Space Limitation—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, […]
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Abrams Talks Social Media at DIA

“It doesn’t turn me on to send a warning letter.” –Tom Abrams, during a Q&A at DIA.  Instead of repeating his yearly Drug Information Association (DIA) conference claim that social media guidance remains among the FDA’s Office of Prescription Drug Promotion’s (OPDP) “highest priorities,” to be published in due course, Tom Abrams, director of OPDP, […]
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Social Media Questions Pharma Companies Should Be Asking

For pharma companies, entering the social media scene is not as simple as just creating a Facebook page or learning how to tweet in 140 characters or less. Social media poses a regulatory and litigation maze that must be carefully navigated. Here, Mathew dos Santos and Lori Leskin provide some insight into the most pressing questions companies are, […]
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