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: February 2009
February is whizzing by. Thankfully, we got through Valentine's Day (bah, humbug). A bill actually got through Congress. Some members of Congress and some party officials have provided quite a bit of humor through their antics and utterances, entirely without … Continue reading
The FDA has a policy and a guidance for companies that want to pursue Formal Dispute Resolution (FDR) . This lays out the procedure by which companies can appeal an FDA decision about a product. It has been demonstrated many … Continue reading
To those who know me, it will come as no surprise to know that when it came time to choosing up sides for basketball during P.E. in grade school, junior high school and high school, I was always one of … Continue reading