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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Category Archives: Useful Resources
Rx 4 Good
In today's environment there is a dichotomy for the pharmaceutical industry when it comes to good corporate social responsibility. Here it is. In the aggregate, the pharmaceutical and biotech industry actually provide a very very large contributions through philanthropy that … Continue reading
Posted in Useful Resources
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FDA Presentation on Responses to 483s
What? What is a 483? A 483 is the vernacular for an FDA inspection of quality standards, manufacturing or the conduct of a clinical trial, and the discovery of deficiencies therein. In other words, theygo through your manufacturing facility, for … Continue reading
Posted in Crisis Communications, Useful Resources
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Medpedia Launches! A Conversation with the Founder of Medpedia
For anyone in healthcare, there is a seismic shift that occurs today. It is the launch of Medpedia – a new Wiki created through the combined efforts of Havard Medical School, the Stanford Medical School, the University of California Berkely … Continue reading
Posted in New and Social Media, Useful Resources
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The Changing Policy and Communications Environment and Implications for Pharma Marketing, Part 3
Here is the last of the 3-part series about the impact of expected upcoming changes in the policy environment and the tremendous migration in the communications environment and how this affects the marketing of pharmaceutical products. In this last installment, … Continue reading
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The Changing Policy and Communications Environment and Implications for Pharma Marketing, Part 2
Today please find the second in a three-part series that looks at the changing policy and communications environments and the challenges and opportunities for pharmaceutical marketing. In Part 1 yesterday, what was covered was the fact that there is a … Continue reading
Posted in Useful Resources
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