Category Archives: FDA

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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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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Bureaucratic Roadblocks Threaten Biopharma Growth

Ahead of the BIO International Convention next week, Jim Greenwood, President and CEO of the Biotechnology Industry Organization, writes that protecting intellectual property rights is vital to biopharma innovation. There is a clear link between a country’s rate of economic development and the strength of its intellectual property laws. This is particularly true in knowledge-intensive […]
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