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: July 2010
Warning Letter Summary thru Second Quarter 2010, Part 1
Looking at things from a strictly quantitative point of view, for sometime now, there has been speculation that the FDA was ramping up enforcement when it came to medical product promotion. That was first seen in 2009 when there was … Continue reading
Posted in Warning Letters 1 Comment
Weekly Roundup – 07/02/10
Dandelions on the front lawn. The buzz of a daring mosquito. Lazy ceiling fans loping above. Blueberry pie, just out of the oven. A picnic is planned. Meat and veggies are tossed on a grill. A three-day weekend begins. Happy … Continue reading
Posted in Uncategorized Comments Off on Weekly Roundup – 07/02/10