About the AuthorMy 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.
My ProfileI 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: September 2017
Weekly Roundup 9.29.17
Everyone has returned from vacations and extended vacations and are cramming to get business done before the year end string of holidays. There is been a good deal of activity this week, so let’s get right down to it. FDA … Continue reading
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Weekly Roundup 9.22.17
Today marks the beginning of autumn and the summer of 2017 is over. The first turning of trees has begun and leaves and acorns are dropping on lawns. The linens have left our closets and we are beginning to think … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 9.22.17
New FDA Directions – Part 3 – Opioids
In this third, and final installment on new directions for FDA under the watch of a new Commissioner, we turn to the issue of opioids. When Dr. Robert Califf was being considered for confirmation as FDA Commissioner he faced a … Continue reading
Posted in FDA Policy 1 Comment
Weekly Roundup 9.15.17
One season winds down, another offers hints of a beginning. I am afraid that both the regular Weekly Roundup as well as regular postings have lately been interrupted by some domestic issues that came up for me as well as … Continue reading
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Weekly Roundup – 9.1.17
As hurricane season made itself felt this week, summer seems over in the east. Kids are back to school and this weekend summer whites and linens have their final appearance before next Memorial Day. Meanwhile it was a very busy … Continue reading
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