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: July 2007
The Importance of Credibility in Public Health
The Reproductive Drugs Advisory Committee experienced some controversy a few years back when a number of extreme conservatives were appointed to the panel, including Dr. W. David Hager. Dr. Hager was noted in many articles for his conservative outlook on … Continue reading
Posted in Current Affairs
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China in Need of Good Crisis Counseling
Every industry and every large company sooner or later faces a crisis. That crisis can be one of many forms. In the pharmaceutical and food industries, when a product is adulterated or causes harm, it is one of the most … Continue reading
Posted in Crisis Communications
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Weekly Roundup – 7/6/07
It was a funny week here in America. We had the 4th of July – Independence Day – stuck right in the middle of the week, leaving many of us to believe that yesterday was the second Monday of the … Continue reading
Posted in Weekly Roundup
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J&J Starts a Blog!
Wow! Johnson & Johnson has demonstrated some very forward thinking as well as guts in launching a new corporate blog called JNJ BTW. Check it out! Here is what the author says in starting the blog: "By The Way… Everyone … Continue reading
Posted in FDA Image
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Anatomy of a Consent Decree
Following yesterday’s posting about catching up, another thing that happened last week is that a Consent Decree was issued by the FDA. The company involved was Shelhigh, Inc., which produces implantable devices. First of all, what is a Consent Decree? … Continue reading