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. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
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 Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York 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.
Posts by Date
Monthly Archives: November 2006
Senator Charles Grassley (R-Iowa) has gone and put a hold on the nomination of Dr. Andrew C. von Eschenbach. There was movement to try to get him approved in the lame-duck Senate session, but the hold would put that into … Continue reading
The elections are over. Campaign commercials are now replaced by Christmas shopping commercials as we enter the home stretch for the year’s end. Thanksgiving is next week when we will be giving thanks, if you can believe it, followed by … Continue reading
Yesterday’s Federal Register carried a notice for meeting on Ketek held by the Anti-Infective Drug Advisory Committee to be held jointly with the Drug Safety and Risk Management Committee. It will be held held on December 14, 2006, from 8 … Continue reading
The witness roster for the peculiarly timed Senate Committee on Health, Education, Labor and Pensions entitled "Building a 21st Century FDA: Proposals to Improve Drug Safety and Innovation" has been filled. The hearing will occur November 16, Thursday at 10 … Continue reading