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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Monthly Archives: June 2011
Weekly Roundup – 6-24/11
Summer officially began. The days have, by seconds only, begun to grow shorter. Storms threaten on a nearly daily basis. Humidity is a constant companion. And today was the last day of school in my neighborhood making me happy once … Continue reading
Posted in Uncategorized Comments Off on Weekly Roundup – 6-24/11
FDA Goes Graphic on New Cigarette Labeling
Last November the FDA announced an intention to up the ante when it comes to labeling for the packages of cigarettes and put on display for our consideration several versions of labels that offered quite graphic warnings on the dangers … Continue reading
Posted in Uncategorized 2 Comments
FDA Launches Initiative Aimed at Imports
There is no question for even the most casual observer that the exploding globalization movement of the 1990s has led to expansive imports during the decade I like to call the Uh-ohs (2000s). Globalization has brought with it many benefits. … Continue reading
Posted in FDA Policy, Food, Safety and Risk Issues Tagged Safety and Risk Issues Comments Off on FDA Launches Initiative Aimed at Imports