About the AuthorMy name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in Washington D.C. 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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Author Archives: Mark Senak
This is it folks, the final stretch. Winter will arrive next week. Travel plans are underway. The last of the gifts are being bought and prepped for the big wrap. And speaking of wrapping up, there are a number of … Continue reading
Given the early arrival of Thanksgiving this year, it should have been a long shopping season, but the walls are already closing in. The days are still growing shorter. The trees and decorations have gone up. We are all in … Continue reading
Today marks the 30th World AIDS Day. It is at the same time breathtaking and heart breaking to note the progress made during the course of this epidemic. In that first year, there were no treatments for HIV/AIDS, transmission was … Continue reading
During all of last year, FDA issued 18 “general announcements” via press release to discuss agency actions on policy issues, announce a point of view or enunciate a policy issue. Two of those from last year included statements that came … Continue reading