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: September 2006
Weekly Roundup – 9-15-06
Sorry to be late this morning, Typepad was having a little trouble waking up. With the passing of another week, we edge closer to autumn. In Washington, it is as if someone turned off the furnace on August 31 and … Continue reading
Posted in Weekly Roundup
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Congressional Micromanagement
To think that members of this particular United States Congress think they can manage anyone else when they do such a poor job of managing themselves is unnerving, to say the least. Overblown budget deficits, bridges built that go nowhere … Continue reading
Posted in Current Affairs, FDA Image, FDA Policy
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Adaptive Clinical Trials – Just Do It!
Some time ago, it became apparent that the FDA was going to participate in a conference on adaptive clinical trials. Dr. Scott Gottlieb, MD, Deputy Commissioner for Medical and Scientific Affairs, Food and Drug Administration — gave a speech on … Continue reading
Posted in Clinical Trials
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Healthcare Communications and the Next Ten Years – Part 3 – PDUFA and Funding for the FDA
This is the third in a series that begins each week and on-going for a number of weeks, exploring specific topics related to changing health policies and their impact on healthcare communications. Let’s look at the money up close, shall … Continue reading
Posted in Healthcare Communications and the Next Ten Years - A Series
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Weekly Roundup -9-8-06
Well, it is time for the Weekly Roundup. It is back to school and back to Congress. For the rest of the world that means more activity, the end of fun and a different way of life. For those of … Continue reading
Posted in Weekly Roundup
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