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: February 2008
I finally did it! I have updated the listing of Approvable Letters that is housed in the left column of the blog under Resources by Me. I now have all of the approvable letters listed that I have seen occur. … Continue reading
Last evening, CBS 60 Minutes ran an investigative report rather dramatically entitled "One Thousand Lives a Month" about the drug Trasylol, manufactured by Bayer for the control of bleeding in patients undergoing surgery. The title of the piece is derived … Continue reading
The pathetic rate of enforcement by CDER continues. I am so stymied why some smart reporter hasn’t posed the question – what is happening when the amount of PDUFA dollars and money in the federal budget for FDA goes up, … Continue reading
Inside the Beltway looking out, it was an exciting week. Super Tuesday helped narrow the field a bit and candidate fundraising has been quite interesting. Looking inside the Beltway, the Senate passed an economic stimulus package aimed at propping up … Continue reading