Category Archives: FDA Policy

Regulatory Considerations in Optimizing a Site for Mobile

Fact: One of the primary uses of the Internet is to seek health information. Fact: By 2015, nearly two-thirds of Americans now have a smart phone; Fact: Of those owning a smart phone, 62 percent have used their phone in … Continue reading

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The Guidance that Dare Not Speak Its Name

In December 2014, Commissioner Hamburg announced a proposed change in the FDA’s long-standing policy regarding blood donations from gay men – See “FDA Commissioner Margaret A. Hamburg’s statement on FDA’s Blood Donor Deferral Policy for Men Who Have Sex With … Continue reading

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FDA Press Releases – 1st Quarter 2015

Last year I began a new database that tracks the press releases of FDA as a way to see what news the agency is talking about and provided a year end look at 2014. Looking back at the quantity and … Continue reading

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 This month, FDA released a new draft guidance document entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk … Continue reading

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