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: May 2007
Sorry no posting yesterday, bad week. And oh dear. Who can believe it? It is already June of 2007. Today every time I went to write the date today I wrote it as 2005. What’s that about? It could have … 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
As noted in this space many times, the images of the Food and Drug Administration as well as the pharmaceutical industry have been suffering greatly, most certainly in the post-COX-2 era. The result has been a rash of lawsuits, congressional … Continue reading
It is hard to believe that it is already Memorial Day Weekend. The year is slipping by so fast. Now we sit on the cusp of summer – the honeysuckle is blooming in my yard and the scent will wash … Continue reading