Category Archives: FDA Policy

Here Comes the Sun – Communications Tips on The Sunshine Data Publication

The Sunshine Act will peek out from behind some, but not all, of the clouds on the horizon soon, leading to a new day in transparency on payments between the medical products industry and those who provide care.  Data will … Continue reading

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So last week there was a lot of interest and commentary on the issuance of a draft guidance by FDA that provided some insight into how the agency is regulating promotional speech and social media platforms.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