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: October 2010
Then and Now – An Interview with Dr. David Kessler, Former FDA Commissioner, Part 4
In this, the final installment of a 4-part interview with Dr. David Kessler, we departed from our discussion about the past and the present to talk a bit about the future. For some time, two developments that have often captured … Continue reading
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Then and Now – An Interview with Dr. David Kessler, Former FDA Commissioner, Part 3
When Dr. Kessler was the Commissioner of the Food and Drug Administration from 1990-1997, approval times for new drugs were lengthy and people wanted faster approval times and easier access to new medicines. This was particularly true given the fact … Continue reading
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Then and Now – An Interview with Dr. David Kessler, Former FDA Commissioner, Part 2
Recently I had the pleasure of sitting down at length with Dr. David Kessler to discuss some of the challenges in the current regulatory environment. In general, throughout the discussion, we talked about how things had changed since his time … Continue reading
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Then and Now – An Interview with Dr. David Kessler, Former FDA Commissioner
Dr. David Kessler was Commissioner of the Food and Drug Administration from 1990-1997, originally appointed by the first President Bush and re-appointed by President Bill Clinton. To be appointed by two presidents of different parties is no small feat in … Continue reading
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Weekly Roundup – 10/08/10
It has been a busy week with a dose of travel thrown in for good measure. The temperature change over the last 10 days has been welcome and remarkable. Some rain fell in biblical quantities. And many in Congress have … Continue reading
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