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 2009
MedReg Wins the Battles, Loses the War
In pharmaceutical companies there is a department called Medical/Regulatory, MedReg for short, that among other things, reviews promotional communications content and form to ensure that it falls within the heavily drawn regulatory parameters outlined by the FDA. MedReg is made … Continue reading
Posted in New and Social Media
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Morningstar on the Wyeth/Pfizer News
Posted in Business/Industry News
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The Importance of Being Washington – The GAO Outlines FDA Reforms
Not the man, the city. On Sunday, January 25, the Washington Post carried an article entitled "The Height of Power – As Other American Fiefdoms Fade, Washington Looms Larger than Ever." It was a very interesting article analyzing the current … Continue reading
Posted in Legislation
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Weekly Roundup – 01/23/09
Late posting today – Typepad was curiously uncooperative today. This week we saw the end of one Administration and the beginning of another, but we also saw more than that. We saw that America once again stood apart from … Continue reading
Posted in Weekly Roundup
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The New Acting FDA Commissioner – Frank Torti
We have seen the big change with the Inauguration of President Obama. In our smaller world concerned with the FDA, there has also been significant change. Dr. Andrew C. von Eschenbach has left the FDA effective January 20, leaving Dr. … Continue reading
Posted in FDA Image
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