About the AuthorMy 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.
My ProfileI 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 BlogEye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. 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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Daily Archives: November 13, 2009
Attending day 2 of the FDA's Part 15 meeting on social media and the promotion of medical products, one has to ponder a question not on the agenda. Has the FDA given up on their big transparency initiative? The question … Continue reading
It is 7:38 AM. People are beginning to filter into the "bunker" as I have begun to call the meeting room at the National Transportation Safety Board, a room so buried that you cannot get a cell signal. It is … Continue reading
The presentations given at the FDA’s Part 15 Meeting on the Internet and Social Media to Market Medical Products today have, generally speaking, been focused more on adding more question logs to the fire, than offering up solutions. There were, … Continue reading