Category Archives: FDA Policy

FDA Guidance Output Plans for 2016

While there has been focus on what FDA accomplished in 2015 – and there will continue to be some of that – it is also a great time to look ahead. What can we anticipate for 2016? This month several … Continue reading

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FDA 2015 Report on New Drug Approvals – A Banner Year

Greetings from the big blizzard of 2016. With life in the slow lane for a bit, it was a good time to catch up on reading. One of those was a recently issued FDA report on the novel new drugs … Continue reading

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FDA Press Release 2015 – What They Said

Last year and the year before, Eye on FDA provided an overview of press releases from the agency for the year that had just passed. The information comes from a database of press releases that I started back in 2013 … Continue reading

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The Growing World of Do It Yourself Health

Sparked by an inquiry regarding a speaking gig around the future of do-it-yourself (DIY) medicine got me to thinking about how much the concept has changed over the years, and most certainly at an accelerating pace. Back in 2011, I … Continue reading

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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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