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.Stay Connected
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I am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!About This Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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Monthly Archives: February 2014
Building a Case, AdComm Preparation, Part 2
Last week, after a talk I gave on the subject, I put up a posting Building a Case, AdComm Preparation, Part 1, where I talked about some of the reasons why communications is almost as important of a factor in … Continue reading
Posted in Advisory Committee Prepapartion
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Reflections on 8 years of Blogging – Eye on FDA Starts a 9th Year
Hello. Eight years ago yesterday – February 9, 2006 – I began this blog with my first posting. Since then, I have published 1250 more postings. Though it seems like only yesterday, 2006 was a very different time: George W. … Continue reading
Posted in About Me
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Weekly Roundup 2.7.14
Well, it has been one long winter. I have the February blues and I am blaming that fact on my being a bit tardy with the Weekly Roundup here. While I love a good snow fall, the fact is that … Continue reading
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Building a Case – AdComm Preparation, Part 1
Today I am giving a talk here in Washington about preparation for advisory committees. Over the years, I have had occasion to attend more meetings of FDA Advisory Committees than I care to think about, often with the purpose of … Continue reading
Posted in Advisory Committee Prepapartion
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Upcoming AdComms by Subject Matter
The Advisory Committee calendar put up by FDA is very useful, but lists the upcoming meetings chronologically by date and by their named committee. I thought it might be helpful every so often to provide an overview of upcoming AdComm … Continue reading
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