Author Archives: Mark Senak

After a Vaccine – What? The Shift from Research and Discovery to Communications

Vaccines for COVID-19 are the focus of the moment – politically and scientifically speaking. On the political front, there has not only been jockeying to try to squeeze the square peg of a vaccine development timeline into a round hole … Continue reading

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For FDA and CDC and the Rest of Us – The Stakes Have Never Been Higher

Since last week’s posting regarding FDA credibility being on the line, there has been a swirl of activity and commentary around the evaluation of vaccine research for COVID-19 that would seem to have exacerbated the problem. For context, last week … Continue reading

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FDA Credibility on the Line

In normal times, when there is no pandemic threatening our lives and livelihoods, it is essential for FDA to maintain the traditional “gold standard” in relation to the decision-making process for the approval of new treatments. That standard is even … Continue reading

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What They Said – A Look Back at FDA Press Releases First Half of 2020

Each year, midway through it all, I take a look back to see what FDA has been talking about and compare it to the year before to see how things may have changed. I’m a little late at getting to … Continue reading

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

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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