Category Archives: FDA Policy

Communications in a Biosimilar Age Almost Upon Us

When policy changes, communications must support the change by informing the stakeholders how it impacts them and the decisions they will have to make. When it comes to biosimilars, now is such a time. The question is – who does … Continue reading

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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 This month, FDA released a new draft guidance document entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk … Continue reading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. ┬áThis 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. ┬áData will … Continue reading

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