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: December 2010
Weekly Roundup
This week we had our first snowfall. The unseasonably cold temperatures have stayed, and so has the Congress, trying to do all of the things it did not do for two years in the last two months. The tree is … Continue reading
Posted in Uncategorized, Weekly Roundup
1 Comment
The Food Administration – The Drug Administration – Legislation Introduced for a Single Agency
Right now, the regulatory jurisdiction for the Food and Drug Administration is huge, overseeing by most estimates approximately one-fourth of the U.S. economy. And in recent months it has expanded into regulating the marketing of tobacco products. Presumably in the … Continue reading
Posted in Food, Uncategorized
1 Comment
Monty Python Meets Pfizer UK
Last week, I had a post that discussed the lackluster use of YouTube by pharma. My point was that the channels themselves are not very engaging or “social” in the way that social media is meant to be. One reader … Continue reading
Posted in New and Social Media, Uncategorized
4 Comments
Guidance on Comments – Advisory Committee Prep on Open Public Comment Period
As noted in the Weekly Roundup on Friday, last week the FDA published a Final Guidance on the Open Public Comment period at FDA Advisory Committee meetings. On a side note, it is perhaps worth noting that this updated the … Continue reading
Posted in Advisory Committee Prepapartion, FDA Policy
1 Comment
Weekly Roundup – 12/10/10
We are staggering through the lame duck and Congress is providing us with lots of reminders as to the unpopularity of the institution. A cold wave has continued to wash over a good part of the nation. Fewer Americans are … Continue reading
Posted in Uncategorized
1 Comment