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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Monthly Archives: March 2009
One of the considerable elements re-shaping the marketing of pharmaceuticals in the United States has been the outlooks and activities and probable future legislation under advisement by members of Congress. While the various actions at the federal level have dominated … Continue reading
March madness is almost over, but my own seems to continue. What's that about? And I don't think the groundhog was right this year, Spring seems to be here in full force, at least by the looks of all the … Continue reading
Something I've written about before is the swing of the pendulum from the 1990s to the 2000s in terms of public priorities for the FDA. What is the balancing act between risk and benefit when it comes to both … Continue reading
Well the long era of suspense is over given the choices by the Obama Administration for the FDA and for HHS – in fact, the appointment game is winding down across the board, and federal agencies are getting down to … Continue reading