Category Archives: FDA Policy

What They Said – FDA Press Releases 1st Quarter 2018

FDA has had a lot to say so far this year. A real lot. In fact, during the first three months of 2018, FDA issued 56 press releases, which is as many as they issued during the entire first half … Continue reading

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FDA’s Strategic Policy Roadmap, Part 3 – Improving Health Care, Access Issues and Public Health

In the last installment we looked at the first part of the Strategic Roadmap – Addiction which specifically focused on opioids and nicotine. However, the next part of the FDA Strategic Policy Roadmap is less specific and instead is focused … Continue reading

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FDA’s Strategic Policy Roadmap – Part 2 Addressing Addiction

With deaths rising each year, there is no question of the urgency that something needs to be done to address the opioid misuse epidemic in the United States. And in addition to mortality there are the lives touched by these … Continue reading

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FDA’s 2018 Strategic Policy Roadmap, Part 1

In January, FDA’s Commissioner announced the release of “Health Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap” that provides a detailed overview of priorities for the agency within a relatively short timeframe. FDA and the various centers that make up … Continue reading

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Taking a Peek at Transparency – An FDA Pilot Program

Yesterday, Commissioner Scott Gottlieb announced a new effort on the part of the agency aimed at increasing transparency around clinical trials, a goal long sought by many patient advocates, particularly outside the U.S.  Specifically, FDA is introducing a pilot program … Continue reading

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