Category Archives: FDA Policy

New FDA Directions, Part 1 – Pricing

With a change in leadership at FDA there naturally a great deal of anticipation with regard to the potential for new direction for the agency and the impact it will have on the agency’s diverse stakeholders. That is especially true … Continue reading

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FDA and Patient Involvement

“I am a cancer survivor, I was treated for cancer during my last tour at FDA, so I k now the importance of what American medicine does — and what the FDA does — for every one of us.” Scott … Continue reading

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What Do Patients Want?

Thirty years ago, HIV advocates elevated the notion of patient involvement in the development of new medicines to entirely unprecedented levels by demanding input into multiple aspects of clinical development of HIV treatments.  That included not only in the way … Continue reading

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How Much Change Does a Commissioner Make?

For the second time in as many years, we have been going through the ritual of getting a new FDA Commissioner appointed. The last one – Dr. Robert M Califf served from February 2016 until January of this year. Dr. … Continue reading

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What They Said – Press Releases 1st Quarter 2017

Anyone who reads this blog knows that apparently I like to count things. Why? Well it provides the basis to confirm or refute general observations, and also can provide perspective that makes you stop and think and wonder. But if … Continue reading

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