About the Author
My 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.Stay Connected
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I 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 2007
Does FDA Labeling Matter Where States Are Concerned?
Recently, the FDA indicated that it would be alright with cloned food, even if it were not so labeled. This was a big mistake. Though many experts have said that it is unlikely that any cloned food would actually end … Continue reading
Posted in Food
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Weekly Roundup – 1/19/07
Though much of the nation has been in a deep freeze, it has been quite balmy here. Though it is finally cold here in the nation’s first city as we are assessing the whirlwind of activity contained in the famous … Continue reading
Posted in Weekly Roundup
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Warning Letter Volume on the Decline
The very day after posting about the upcoming FDA meeting on PDUFA IV, I was getting ready to check out the Warning Letters for the 4th Quarter when I decided to look back on the DDMAC issued letters going back … Continue reading
Posted in PDUFA, Warning Letters
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PDUFA IV Meeting Announcement
In today’s Federal Register, there is a whopping entry published from FDA regarding that publishes proposed recommendations for PDUFA IV that will cover years 2008-2012. Whopping refers to its length- 11 pages in PDF! It makes good reading if you … Continue reading
Weekly Roundup – 01/12/07
My apologies for the lack of postings this week. The new year has gotten off to a quite busy start and I was on the road, but unable to access Typepad so that I could post. I hope to make … Continue reading
Posted in Weekly Roundup
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