About the Author
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
Category Archives: FDA Policy
Approvals in the Crazy Year of 2020
Each year in January, it is relevant to look back on the activities of FDA during the course of the previous year and look at how it was the same or different from prior years, and to look at trends … Continue reading
Posted in Advisory Committee Prepapartion, FDA Image, FDA Policy
Tagged #pharma, Drug Approvals
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FDA AdComm Agenda Covers the Bases
First of all, we are having a bit of a crisis with our crisis. As we appear to be moving into yet another wave of COVID-19 infections, and as research into a vaccine is aggressively underway, we also see serious … Continue reading
Posted in Advisory Committee Prepapartion, COVID19, Current Affairs, FDA Image, FDA Policy
Tagged #COVID19
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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
Posted in FDA Image, FDA Policy
Tagged #FDA #COVID19 #EUA #BloodPlasma
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Look Back – Drug Approvals First Half of 2020 Amidst the COVID Challenge
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
Posted in Approval Announcements, FDA Policy
Tagged Drug Approvals, FDA, Pharma
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FDA to Hold Virtual AdComm
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
Posted in Advisory Committee Prepapartion, FDA Image, FDA Policy
Tagged #AdCom, #AdComm, #FDAAdvisoryCommittee
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