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.
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 BlogEye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. 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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Category Archives: Proposed Legislation
We are days away from the mid-term elections. Don’t worry, this isn’t another piece to read about how the Senate could hang in the balance for weeks; or how one party or another might retain or take control of any … Continue reading
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
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
It has been a while since providing an update on legislative proposals introduced in Congress that would impact the FDA, medical products and food industries. With Congress out on recess, it seemed like a good time to catch up on … Continue reading
Before the re-design of the blog, off to the right I had a lengthy list of proposed legislation in the 111th Congress with links to the actual legislation. This includes laws aimed at health care access, at the FDA itself, … Continue reading