Category Archives: FDA Policy

FDA Adds a New AdComm for Patients

This week FDA published a Federal Register announcement stating that the agency was establishing a new Patient Engagement Advisory Committee designed to provide counsel to the Commissioner on issues related to medical devices. The agency said that the scope is … Continue reading

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Then and Now – Shutdown Showdown

The last time we faced a government shut down, there were some advance communications on how various government agencies were going to be operating during the “event”. Last time, the executive brand had issued a memorandum on September 17, this … Continue reading

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FDA Press Releases – First Half of 2015

As regular readers may remember, I have started a database that tracks FDA press releases that goes back through 2014 and provided an overview of the 2014 press releases (See – FDA Press Releases – What They Said and How … Continue reading

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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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