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.
Posts by Date
Legislative Tracking Tools
Monthly Archives: November 2013
Warning and Untitled Letters and Spoken Words
Pulling on my database on Warning and Untitled Letters over the past ten years, I had occasion to look up those violations over the past 10 years that involved the spoken word. The database profiles each letter and tracks various … Continue reading
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Weekly Roundup 11-22-13
As many of us get ready to hit the road this week to spend the holiday with friends and family during this season when we give thanks and take stock of our many blessings, I will voice one now. Thanks … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 11-22-13
Weekly Roundup – 11-15-13
Many people this week are disappointed, chagrined even, to realize that Thanksgiving is not next week. Well, if not many, then me. Seriously, it is very late this year….and it is my favorite holiday. Still, I am somewhat grateful for … Continue reading
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Warning Letters and Boxed Warnings
My data base on warning and untitled letters now includes the years 2004-today. It includes 282 letters covering a neat total of 1000 different violations. When I was working on it earlier, I did a post looking at letters aimed … Continue reading
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Weekly Roundup – 11-8-13
Oh dear. I originally dated this Weekly Roundup as being in 2011. That is the kind of week it has been – I’m not even sure what year it is. The time of year, however, is obvious, with multi-tinted leaves … Continue reading
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