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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Legislative Tracking Tools
Monthly Archives: August 2006
GovTrack.US
Just a quick post to let you know that I’ve installed a link to a very good tool called GovTrack.US which allows you to track legislation that you are interested in. Given the heavy amount of interest in the Kennedy-Enzi … Continue reading
Posted in Useful Resources
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Weekly Roundup – 8/11/06
Another week of dog days of summer have past. (The term, by the way, dog days of summer is related to the fact that Sirius, the dog star, is out during this time and rises and sets with the sun. … Continue reading
Posted in Weekly Roundup
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Weighing the Benefits of Adaptive Clinical Trial Designs – An Update
As stated yesterday, there is a great deal of interest in the upcoming workshop on adaptive clinical trial design to be held in November in the Washington area. While plans have not yet been finalized, here are some insights. The … Continue reading
Posted in Clinical Trials
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While Waiting for the FDA’s Adaptive Clinical Trials Workshop….
Ever since Dr. Scott Gottlieb’s speech on adaptive clinical trials, and my posting on that topic, I have sensed an extraordinary amount of interest in the upcoming FDA workshop and in the topic itself, particularly from pharmaceutical companies. The FDA … Continue reading
Posted in Useful Resources
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Anti-depressants and Kids
A new study came out that documents the point of view that the use of anti-depressants might be factor in teen suicide. It is disturbing to think that drugs that are developed to help might do harm. I would not … Continue reading
Posted in Current Affairs
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