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: February 2009
Nice Examples of YouTube PSAs by the American Cancer Society
The growing use of YouTube as a means to reach specific healthcare audiences is growing. I've often written about the remarkable utility of YouTube in putting together public service announcements (PSAs) that can be picked up by target audiences and … Continue reading
Posted in New and Social Media
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Weekly Roundup – 2/20/09
February is whizzing by. Thankfully, we got through Valentine's Day (bah, humbug). A bill actually got through Congress. Some members of Congress and some party officials have provided quite a bit of humor through their antics and utterances, entirely without … Continue reading
Posted in Uncategorized
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Gilead Demonstrates the Folly of Formal Dispute Resolution
The FDA has a policy and a guidance for companies that want to pursue Formal Dispute Resolution (FDR) . This lays out the procedure by which companies can appeal an FDA decision about a product. It has been demonstrated many … Continue reading
Posted in Complete Response Letters
1 Comment
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
1 Comment
Do We Really Know What Comparative Effectiveness Means?
To those who know me, it will come as no surprise to know that when it came time to choosing up sides for basketball during P.E. in grade school, junior high school and high school, I was always one of … Continue reading
Posted in Legislation
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