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.
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Legislative Tracking Tools
Monthly Archives: June 2007
How About Some Macromanagement?
There is no shortage of members of Congress who are hot to oversee the FDA activities – Congressman Henry Waxman, Senator Charles Grassley and Congressman Bart Stupak, to name but a few. I do not begrudge anyone from holding a … Continue reading
Posted in Current Affairs 2 Comments
New Media and Pharma – An Intermittent Series
Feed me! A few weeks ago, I was speaking to a group about pharmaceutical companies and new media. I have written posts on this blog about the slowness with which the industry has embraced new media – with some putting … Continue reading
Posted in Tutorial 3 Comments
Weekly Roundup – 6-22-07
Yee Ha – Summer came at us this week and boy it was hot at the start! Summers in Washington have a few perks, however. Traffic is way down. Congress leaves town. The produce is great. And of course, like … Continue reading
Posted in Weekly Roundup 1 Comment
Two More Approvable Letters Issued
Wow – the approvable letters are flying off the shelves. If you are not familiar with approvable letters, see my posting "What Does Approvable Mean?" Or you may wish to listen to my podcast on the subject of approvable letters. … Continue reading
Posted in Approvable Letters Comments Off on Two More Approvable Letters Issued
Europe Lags in Feeds – FDA Wins!
As you know, I am proponent of the use of feeds to spread information and have written frequently on the topic. Feeds are an extremely efficient method for disseminating news and conform to the way people are using the Internet … Continue reading
Posted in Current Affairs Comments Off on Europe Lags in Feeds – FDA Wins!