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: June 2009
I am really sick of rain. Really. This morning there was a duck floating in my back yard. A duck. Here is what happened this week that was interesting to me and I hope will be to you too. FDA … Continue reading
For a long time now, I've been convinced that there would emerge something on the order of a FPUFA (Food Producer User Fee Act) not only because it is fun to say, but because for a long time, there has … Continue reading
Yesterday the Obama Administration announced a new Task Force at FDA to delve into the issue of transparency. Later that same day, the FDA opened up a new part of its Web site devoted to FDA transparency and launched a … Continue reading
The New York Times reports that the Obama Administration will announce today that a panel will be formed to make recommendations on how information about FDA decisions can be made more transparent related to approvals for drugs and devices. That effort … Continue reading
Last week I posted Part 2 of the examination of the past two quarters for FDA DDMAC letters. The week before that, I posted Part 1. Finally, I am done with Part 3, examining the last quarter of 2008 and … Continue reading