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: October 2006
Lettuce Beware
Let’s face it, it has been a bad season for vegetables. To date, there have been 199 cases of E coli from spinach in 26 states. Each day, the FDA has been issuing spinach status updates on the situation which … Continue reading
Posted in Current Affairs, FDA Image, Food
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Synopsis of the Congressional Budget Office Report on the Future of Pharmaceuticals
On Friday, I mentioned that last week the Congressional Budget Office issued a report entitled "Research and Development in the Pharmaceutical Industry". Over the weekend, I got to read the 65-page report in detail and found it quite interesting. The … Continue reading
Posted in Current Affairs
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Weekly Roundup 10-6-06
Alas, where has the week gone to? It is time for the weekly round up. As scandal breaks in our nation’s city, and the Congress is in a scramble right at election time, we inside the Beltway are wondering what … Continue reading
Posted in Weekly Roundup
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Warning Letter Summary for Third Quarter 2006
The rate of Warning Letters coming from DDMAC for violations by pharmaceutical companies continues to come out a slow-paced drip. The third quarter of 2006 produced only four letters from DDMAC for communications issues. DDMAC reviews all types of communications … Continue reading
Posted in Uncategorized
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A Study of Statins
There is perhaps no better candidate in the pipeline for an RX to OTC switch than for statins. Statins lower cholesterol dramatically and therefore one can intuit – they would lower the rate of heart disease in this country if … Continue reading
Posted in OTC Switches
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