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: March 2016
One area of FDA activity that I like to track is in relation to advisory committees which I think provide us with something of a surrogate marker for the pace at which FDA is considering and approving new drugs. To … Continue reading
Well the first quarter of 2016 has sure blown by. We had the earliest Equinox since the 19th Century. Someone flipped a switch and everything started blooming at once. The cherry blossoms got well underway this week. And here is … Continue reading
One Tuesday morning early in October in 1988, a large group of protestors appeared in front of the building that housed the Food and Drug Administration and effectively shut the agency down. There were hundreds of protesters present, organized by … Continue reading
St. Patrick’s Day is behind us, Easter is before us. And yet, there is a forecast of snow for our area here in the mid-Atlantic looming before us for the weekend. Yes, it is that delightful time of the year … Continue reading
People like to get information from people they trust. Moreover, a hallmark of digital communications has been a turning away from large, institutionalized sources for information and turning instead to hear from individuals. Pew Research has shown that especially for … Continue reading