Author Archives: Mark Senak

Weekly Roundup 8.11.17

I’ve decided to bring back the Weekly Roundup. I have missed it and especially now with the prospect of a good deal of change in healthcare in general and FDA in particular, much more is happening than I would ever … Continue reading

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New FDA Directions, Part 2 – Cures Implementation

In Part 1 of FDA New Directions, we looked at the issue of pricing. Today we’re looking at implementation of the 21st Century Cures Act (the Act). Prior to becoming the FDA Commissioner, Dr. Gottlieb was a strong supporter of … Continue reading

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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 They Said – 2nd Quarter 2017

During a somewhat slow week given the holiday that coincides with the end of the second quarter, this is a good time to look back at press releases for the quarter and the year so far. A single press release … Continue reading

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