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 Image
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
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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Impact of COVID-19 on Regulatory Enforcement and Approvals
The impacts of the COVID-19 pandemic bring change shifts the status quo on a daily basis with both breadth and depth. Everything we as individuals and as a society would normally do is undergoing change. FDA regulatory oversight is one … Continue reading
Posted in Current Affairs, FDA Image, FDA Policy
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What They Said – A Look at Press Releases Issued by FDA in 2019
It is time to look at the forest rather than the trees. It has been a regular custom to occasionally look back and see what FDA has been saying, and how frequently the agency has been saying it and what … Continue reading
Posted in FDA Image, News
Tagged FDA Press Releases
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2020 Vision – Notable FDA Actions During 2019
Happy New Year! It is 2020 – the year of clear vision. Let’s look back for a bit as we plunge forward. FDA is a giant agency where a lot happens. Narrowing down the actions of significance is therefore a … Continue reading
Posted in FDA Image, FDA Policy
Tagged FDA 2019, FDA Approvals, FDA CBD, FDA Enforcement
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