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: October 2013
Weekly Roundup – 10-25-13
Well, there is definitely a bite of autumn crispness in the air and I think we are on the verge of first frost. The days are noticeably shorter. Daylight savings (always thought it a funny name for it) is upon … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 10-25-13
Warning and NOV Letter Summary – 3rd Quarter 2013
Government shut down or no government shut down, the read for Warning and NOV letters out of the Office of Prescription Drug Promotion (OPDP) is slim pickings. It is always a good idea at the end of the quarter to … Continue reading
Posted in Warning Letters Comments Off on Warning and NOV Letter Summary – 3rd Quarter 2013
Weekly Roundup – 10-11-13
For Washington, it is real quiet. This week on my way to work while driving past the Lincoln Memorial, there was a man with a lawn mower unofficially mowing the lawn. The Federal Register which reports on all of the … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 10-11-13
AdComms and the #Shutdown
People are looking for black and white answers about what government agencies in general are going to do during the shutdown respecting specific operations. One of the specific areas of interest at FDA has been whether or not there will … Continue reading
Posted in Advisory Committee Prepapartion, Current Affairs Comments Off on AdComms and the #Shutdown