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: April 2010
Warning Letter Summary, First Quarter 2010, Part 1
Note: After this posting was originally published on the morning of April 7, the FDA posted additional NOV and Warning letters to its site that were issued in the month of March. The numbers were changed to reflect the new … Continue reading
Posted in Warning Letters
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How Many i-Pads Did FDA Get?
Probably zero. But if that is the case, it is one less than they should have gotten. Why? Because they, and all communicators, need to understand how it works if they are going to communicate well with it. The … Continue reading
Posted in Uncategorized
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Linking in Docs –
Last week in Berlin I was fortunate enough to sit on a panel at the Second Annual ExL Digital Pharma Conference in Berlin with Matt Jameson Evans, the gist of which was geared to putting the medical products industry into … Continue reading
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Weekly Roundup – 04/02/10
The daffodils are expressing their buttery flavored confidence; tulips look robust and ready to pop; the garden beds are mulched and the deck newly stained. The barbeque pit is cleaned and pansies reside in all of the flower boxes boasting … Continue reading
Posted in Uncategorized
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