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: March 2012
Weekly Roundup – 3-9-12
In late August while on my morning dog walk, I saw a neighboring Dad in his front yard with his five year old daughter getting ready for her first day at school. She was wearing pink and had a pink … Continue reading
Posted in Weekly Roundup
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Interesting FDA Facts and Figures from Commissioner Hamburg’s Testimony on Budget
On February 29, FDA Commissioner Margaret Hamburg delivered FDA’s budget request in testimony before the U.S. House Committee on Appropriations, Subcommittee on Agriculture, Rural Development, FDA and Related Agencies. FDA is of course a very large agency with varied responsibilities … Continue reading
What Does an Evolving OTC Environment Mean?
Once upon a time, it was quite common for drugs to switch their status from prescription to over-the-counter (OTC) making them much more accessible to people by means of ability to purchase and cost. Allergy medications and heartburn treatments saw … Continue reading
Posted in OTC Switches
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Weekly Update 3/2/12
Spring is not waiting for the Vernal Equinox. Spring didn’t even wait for winter – it feels like it has been here for a while. Daffodils are already in full bloom around town, tulips up. If you were planning on … Continue reading
Posted in Weekly Roundup
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The Evolving Nature of AdComm Watching – Not for the Birds
Some people watch birds. They get field glasses, walk in groups in wooded areas, and observe, catalog, and discuss birds. There are volumes of books written about various aspects of bird watching. Different shapes, different sizes, different species. I’ve noticed, … Continue reading
Posted in Advisory Committee Prepapartion
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