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. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
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 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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Category Archives: Drug Safety
On Sunday, two of the nation’s leading papers, the New York Times and the Washington Post both carried front page articles relating to the safety of medical products or components of medical products from China. The Times article, "FDA Tracked … Continue reading
I attended the House Committee on Government Oversight and Government Reform hearing on the GlaxoSmithKline diabetes drug Avandia yesterday. It was crowded and heated, both literally and figuratively. If you are interested in watching the video of the Avandia hearing, … Continue reading
Yesterday the FDA announced the formation of the Risk Communication Advisory Committee – a new 15 member committee solely dedicated to help FDA better understand the communication needs and priorities of the general public; advise FDA on the development of … Continue reading
This year, Senators Charles Grassley (R-Iowa) and Max Baucus (D-Mont) have been on more of a tear than usual regarding the FDA. A lot of their focus this year has been on post-marketing surveillance of drugs and devices. They are … Continue reading