Category Archives: FDA Policy

Collection of FDA and Social Media Resources

Many years have passed since FDA began attempting to enunciate a regulatory approach to digital and social media – beginning in 2009 and still presumably on-going.  In June the most substantive guidance yet was released by the agency addressing two … Continue reading

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Mind and Heart

The Washington Post recently carried an article regarding an investigative compound being studied for the treatment of Duchenne muscular dystrophy which affects young boys – a condition for which there is no current treatment.  The course of the condition means … Continue reading

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FDA Press Releases – What They Say

Keeping my eye on FDA, and being most interested in communications, AND having a penchant for looking at patterns through databases, I started categorizing FDA press releases to see what they talked about and in what way.  I only started … Continue reading

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Looking Back Down the Road – What Have We Learned from FDA on Regulation of Digital Media?

So last week there was a lot of interest and commentary on the issuance of a draft guidance by FDA that provided some insight into how the agency is regulating promotional speech and social media platforms.  It seemed like a … Continue reading

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Fewer Letters, Fewer Warning Letters

It may seem that I write a lot about the letters that FDA puts out regarding industry promotion and communication, but that is exactly what the nature of this blog is about. Other things can be interesting, particularly policy developments, … Continue reading

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