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: January 2016
Weekly Roundup 1.29.16
Well, we have gotten through the first month of the year. We had a lot of days with some pretty warm temperatures and it was evident that many of the daffodils had the idea that it might be a good … Continue reading
Posted in Weekly Roundup
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FDA 2015 Report on New Drug Approvals – A Banner Year
Greetings from the big blizzard of 2016. With life in the slow lane for a bit, it was a good time to catch up on reading. One of those was a recently issued FDA report on the novel new drugs … Continue reading
Posted in Approval Announcements, FDA Policy
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Weekly Roundup 1.22.16
Well, you remember last week perhaps in the Weekly Roundup when I lamented the lack of snow and commented on the fact that it can be quite enjoyable when there is a big snowfall that brings the world to a … Continue reading
Posted in Weekly Roundup
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Weekly Roundup 1.15.16
In the mid-Atlantic, it has been a winter without snow. In fact, despite a few genuinely chilly days, it has largely been balmy. I know some people don’t miss it – in fact perhaps most. But I always think there … Continue reading
Posted in Weekly Roundup
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FDA Press Release 2015 – What They Said
Last year and the year before, Eye on FDA provided an overview of press releases from the agency for the year that had just passed. The information comes from a database of press releases that I started back in 2013 … Continue reading
Posted in FDA Image, FDA Policy
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