Monthly Archives: July 2020

The Fourth Quarter Will Have Little Oxygen – Implications for Healthcare Milestones

Posted on July 31, 2020 by Mark Senak

Given the state of things in 2020, a lot of us are already thinking about when it will end. Moreover when it does end, it will be good riddance. That said, this difficult year will not go quietly into the … Continue reading →

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Look Back – Drug Approvals First Half of 2020 Amidst the COVID Challenge

Posted on July 28, 2020 by Mark Senak

As the year began, no one really thought that within a few months, the systems upon which we rely on for just about everything would be so severely disrupted and tested by the presence of something we cannot even see … Continue reading →

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FDA to Hold Virtual AdComm

Posted on July 8, 2020 by Mark Senak

I don’t usually publish the scheduling of an AdComm with a blog posting. But this one merits one. With fewer than the usual minimum of fifteen days’ notice, FDA has scheduled an FDA Advisory Committee meeting of the Cardiovascular and … Continue reading →

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Time for FDA’s OPDP to Fill the Gaps on Digital and Social Media

Posted on July 7, 2020 by Mark Senak

At mid-year, it has been a custom here at Eye on FDA to look back at a few categories of activity by FDA at the first half of the year and discern what it tells us about future directions. This … Continue reading →

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