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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My Favorite Dogs
Monthly Archives: May 2012
This is it! Memorial Day weekend! BBQs, straw hats, white pants, white bucks, seersucker suits and shorts, flip flops, the beach, clam bakes, trashy novels, front porch rockers, fresh baked fruit pies, beefsteak tomatoes, corn on the cob! Ah summer! … Continue reading
I kept thinking that this was going to be Memorial Day weekend and I was wrong each time, but it is Victoria Day weekend in Canada, so perhaps I was just channeling a 3-day weekend from my northern friends. Â Happy … Continue reading
Another quarter has zoomed by. And with it, FDA’s Office of Prescription Drug Promotion (OPDP), formerly known as the Division of Drug Marketing, Advertising and Communications (DDMAC), has issued a stream of regulatory action letters known as Notice of Violation … Continue reading