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: October 2010
Weekly Roundup – 10/29/10
Last week, I never got to hitting publish on the Weekly Roundup, so this week you get two weeks' worth… First frost has not yet arrived, but there is anticipation it could happen tonight. There will be no frost on … Continue reading
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Warning Letter Summary thru Third Quarter 2010, Part 1
(Note: On November 15, 2010, a correction was made to this post due to a mistake in the count on the number of DDMAC letters issued. By error, two letters from the fourth quarter had been added in. Apologies … Continue reading
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Day One at the Pharma ExL Conference East – Philadelphia
How does one even begin to sort through all of the health care information that is on the Internet today? Getting health care information is one of the most commonly sought pursuits on the Web. But the volume and variance … Continue reading
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Weekly Roundup 10-15-10
Now we are really in the swing of autumn. Leaves, having lost their access to long hours of sunlight, are now shedding and filling the back deck with reminders of summer. Halloween candy in gargantuan bags appears in grocery stores … Continue reading
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