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: February 2009
Guidance Calendar from FDA
The FDA today released its Guidance Calendar for 2009. It is perhaps as interesting for what is not on the calendar as it is for what is on the calendar. Many Med/Reg people long for guidance from the FDA on … Continue reading
Posted in Uncategorized
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J&J and Social Media – How’d They Do It? A Conversation with J&J
Johnson & Johnson has gone far in establishing a digital footprint that has both breadth and depth to it. The company's YouTube channel now has over 90 videos – not branded, but patient educational. That is more than SanofiPasteurTV, GSKVision … Continue reading
Posted in New and Social Media, Podcast
9 Comments
ABC News – Daschle Withdraws
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Posted in Current Affairs
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Obama’s Pick for FDA Commissioner Gets Closer
According to this morning's Washington Post, President Obama is moving much closer to picking an FDA Commissioner. In an article entitled "Obama Faults FDA on Food Safety" by Lyndsey Layton, regarding a new FDA Commissioner, it is stated "…the White … Continue reading
Posted in FDA Policy
1 Comment
Twitter Communications in a Time of Crisis – The Great Peanut Recall
It would be impossible for you not to have heard that there has been a problem with peanuts that were processed at a particular plant in Georgia, resulting in a salmonella outbreak nationwide. The sheer number and volume of product … Continue reading
Posted in FDA Image, Food, New and Social Media
4 Comments