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: November 2007
It is hard to believe we sit on the cusp of December and 2008. And to celebrate the new year, we are going to have a bunch of primaries that are going to keep our focus on a year long … Continue reading
A few weeks ago, on November 15, I reported on the public meeting held by the FDA to elicit input on the idea that drugs might have a new class beyond prescription and over-the-counter, called behind-the-counter, dispensed and, in essence, … Continue reading
Last week, I had the good fortune to sit down with Dr. David Acheson, Assistant Commissioner for Food Safety at the Food and Drug Administration. I had wanted to meet him ever since reading about him in the Washington Post … Continue reading
Because the Democrats seem to dominate the beginning of the alphabet, this is the first opportunity I’ve had to review a Republican in this on-going series. With the Democrats so far, we have seen each – Biden, Clinton, Dodd and … Continue reading
Given the holiday week, there is no Weekly Roundup this week, but my eye did catch an interesting tidbit that made me want to re-visit the issue of appealing an FDA decision. I last wrote about it on July 17 … Continue reading