Category Archives: FDA Policy

Treating the Patient, Not the Symptoms – FDA and Digital Health

Last week Commissioner Scott Gottlieb delivered remarks at the Health Datapalooza, the meeting representing a nexus between innovation in digital health and the world of policy. He began his talk by saying that for most of the last century, medical … Continue reading

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FDA Enforcement Lags, Focus on Promotion of Unapproved Drugs

It goes without saying that enforcement by FDA’s Office of Prescription Drug Promotion (OPDP) as identified through regulatory action letters (warning or untitled) over the past few years is a mere shadow of its former self. Enforcement was once robust, … Continue reading

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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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