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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Monthly Archives: August 2014
For the past few years here in Washington, the summer ended in August seemingly with the flip of a switch following Labor Day Weekend. The daily threat of storms abated, the high humidity retreated, air conditioners were switched off in … Continue reading
FDA’s OPDP views nearly all industry communication – whatever the venue and intent – through a lens of advertising. Certainly a big focus of regulatory enforcement has been direct-to-consumer advertising and for a long time, there has been guidance available … Continue reading
In June I put on a Webinar about the communications impact and considerations respecting the upcoming release of data from CMS under the terms of the Sunshine Act. That followed a blog posting from April. The point in both of … Continue reading
It is hard to believe that I see on Facebook many of my friends who are parents talking about their kids headed back to school this week. Back to school? Back to school? Why when I was a lad, which … Continue reading