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: March 2013
Weekly Roundup – 3-29-13
Spring has started, but not sprung. Not really. In the days since Spring first started a mere 9 days ago, we have had more snow in the Washington, D.C. area than we had all winter. Still, the daffodils have shown … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 3-29-13
Upcoming FDA Advisory Committee Meetings and Topics
In January Eye on FDA ran a look at the upcoming advisory committee meetings and their topics and it is time for an update. It turns out that April is a ridiculously busy AdComm month, but there are some interesting … Continue reading
Posted in Advisory Committee Prepapartion Comments Off on Upcoming FDA Advisory Committee Meetings and Topics
Weekly Roundup! Back again! – 3/22/13
I miss doing the Weekly Roundup and so I am bringing it back. Part of the reason that it subsided is that I have been working hard on a rather large project that is now concluded, so let’s round up … Continue reading
Posted in Weekly Roundup 1 Comment
Last week I posted some of the latest legislative proposals out of the 113th Congress that would affect either some aspect of the pharma industry or FDA. That information is housed on a tab on the Eye on FDA site … Continue reading
Posted in Proposed Legislation, Useful Resources Comments Off on Tracking Legislation
Proposed Legislation in the 113th Congress
During the course of the 112th Congress, there was a good deal of legislation introduced that, if passed, would impact either the pharmaceutical industry or FDA itself. Much of that legislation did not pass but some of it has found … Continue reading
Posted in Proposed Legislation Comments Off on Proposed Legislation in the 113th Congress