Category Archives: FDA Policy

The Language of Risk – FDA’s Evolution of Thought

How does the average patient assess the risk of a medical product when deciding whether or not to seek it out? This month, FDA released a new draft guidance document entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk … Continue reading

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FDA’s Novel Year of Novel Drug Approvals – 2014

Of course it is more than a roll of the dice. A lot of work and effort goes into medical treatment applications for approval and into evaluating them for consideration. As was widely discussed in FDA-watching circles, the agency approved … Continue reading

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FDA Press Releases – 2014 What They Said and How They Said It

Last year, Eye on FDA had a posting that examined the press releases of the previous year, relying on a new tracking system I had implemented for that purpose.  This being the second year of the database, we can not … Continue reading

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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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