Author Archives: Mark Senak

Weekly Roundup 12.8.17

Given the early arrival of Thanksgiving this year, it should have been a long shopping season, but the walls are already closing in. The days are still growing shorter. The trees and decorations have gone up. We are all in … Continue reading

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Weekly Roundup 12.1.17

Today marks the 30th World AIDS Day. It is at the same time breathtaking and heart breaking to note the progress made during the course of this epidemic. In that first year, there were no treatments for HIV/AIDS, transmission was … Continue reading

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A Manner of Speaking

During all of last year, FDA issued 18 “general announcements” via press release to discuss agency actions on policy issues, announce a point of view or enunciate a policy issue. Two of those from last year included statements that came … Continue reading

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Weekly Roundup 11.17.15

We have no sooner gotten rid of the candy from Halloween then we are preparing to receive our Thanksgiving guests and putting together menus for the big day, only to rush headlong into the next holiday season that will involve … Continue reading

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The Convergence of Digital Health, Devices and Pharma

There has been a huge push in policy circles to speed innovation in medicine which is manifest in several initiatives, including most notably the 21st Century Cures Act implementation. But it would be a mistake to assess the quickening pace … Continue reading

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