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: January 2014
Weekly Roundup 1-10-14
As we all emerge from the first full work-week of the new year, there is among many a sa strong shared sense that the last 5 days have actually been more like 5 weeks. And even though it seemed like … Continue reading
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Warning and NOV Letter Summary – 4th Quarter 2013
I usually wait a little bit longer after the end of the quarter to write up a summary of letters issued by the Office of Prescription Drug Promotion (OPDP) because there can sometimes be a healthy lag time between the … Continue reading
Posted in Warning Letters 1 Comment
Weekly Roundup 1-3-14
What? A Weekly Roundup after such a short quiet week? And a week when there was a snow storm to boot? Even these sheepdogs can’t find the sheep to round up! Well it may have seemed like a quiet, … Continue reading
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A Look Back at 2013 and FDA
Happy New Year! It is natural for each of us to look back on the year and see where we did well and where we stumbled and also to assess how the past year might shape the one to come. … Continue reading
Posted in Uncategorized 1 Comment