Tag Archives: FDA

FDA’s Patient Outreach: Finding Ties that Bind

Is the FDA doing enough to incorporate the patient perspective in the drug review process? This was the key question considered at a panel of regulatory experts held at last month’s annual BIO International Convention in San Diego. The consensus: while FDA deserves high marks for effort, both in reconciling the diversity of patient organization […]
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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 […]
Posted in compliance, E-Media, FDA, Guest Blog, Op-Ed, Regulatory, social media | Also tagged | 1 Comment

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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US Regulators and Industry Bodies Push Forward with Global Expansion

At the annual meeting of the Food and Drug Law Institute (FDLI) this year, FDA commissioner Margaret Hamburg concluded her keynote address by describing a “dramatically changing global marketplace” and its “huge implications” for FDA’s ability to ensure the safety and quality of products manufactured elsewhere. In addition to conducting more inspections and oversight of […]
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Suffer Little Children? To Medicate or Not to Medicate Toddlers

When Audre McDonald accepted her sixth Tony Award (theater’s version of the Academy Awards) this month in New York City, and broadcast live on national television, she thanked her parents “for their unwillingness to put her on stimulant medication, which she believed led to her stunning success in musical theater.” In the aftermath, her comments […]
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