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 2009
Will the FDA Part 15 Meeting on Social Media Actually Bring on a Global Freezing?
The FDA is finally holding a meeting to gather input about the agency's role in providing some guidance respecting the use of social media by the medical products industry. It is long overdue, as mentioned many times here. The … Continue reading
Posted in FDA Policy, New and Social Media
2 Comments
FDA’s Strategic Plan for Risk Communication, Part 1
Suddenly, out of almost nowhere it seems, a document emerged from the FDA entitled "FDA's Strategic Plan for Risk Communication" and was simply dated "Fall, 2009". In it, the agency lays out its thinking with respect to risk communications, particularly … Continue reading
Posted in FDA Policy, New and Social Media
2 Comments
Google Wave – An Update After Nearly a Week of Use
I love the idea of Google Wave. I still think it has tremendous potential. But after playing with it for a week, there are some issues. There is a Google Wave conundrum. On the one hand, Google Wave offers really … Continue reading
Posted in Uncategorized
3 Comments
Weekly Roundup 10-16-09
Well partners, another week has flown by and it is cold and rainy in Washington, D.C. where health care reform has finished its umpteenth week and continues its slow progress. My Google Wave invite arrived and I've been busy playing … Continue reading
Posted in Uncategorized
Comments Off on Weekly Roundup 10-16-09
Day 1 of Google Wave – A Blank Canvas
My Google invite was in my inbox yesterday morning. At 6:34 AM I opened my account. Here is what I saw. Nothing. That is because when you open your account, you are all alone. It was like landing on … Continue reading
Posted in New and Social Media
3 Comments