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: June 2006
Sorry everyone, am dealing with the rains here in DC. Will be in full force next week! Share this:
I’ve been on the road traveling for several days and lots has been happening. The occasion of the 100th anniversary of the FDA’s existence has sparked a great deal of commentary. Gang up! Remarkably, all on the same day, Public … Continue reading
You have to admire Washington. It is the only city in the United States where, when you don’t do anything, you make news. At least if your name is Supreme Court. Monday the Associated Press noted that the Supremes have … Continue reading
When an investigational product is working its way down the clinical trial path, it is natural for a drug sponsor to want to communicate about its progress. But when it comes to pre-approval communications, there are some caveats, particularly respecting … Continue reading
Recently Merck announced a lowering of the price of Zocor (simvastatin) in a move that presumably will put their brand name drug in a competitive position vis a vis an upcoming generic product, just approved by the FDA. This brought … Continue reading