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: September 2009
FDLI Conference – Part 2 – Janet Woodcock Speech
At the opening of the 20th Food and Drug Law Institute Conference Annual Advertising and Promotion Conference, CDER's Dr. Janet Woodcock stood in for Dr. Margaret Hamburg who was said to have had a scheduling conflict due to a meeting … Continue reading
Posted in DTC Advertising, FDA Policy
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FDLI Conference Part 1
Well it is an interesting turn of events. The Food and Drug Law Institute is holding a large conference here in Washington on September 21- 22. Heading up the list of speakers was billed to be Dr. Margaret Hamburg, the … Continue reading
Posted in FDA Policy
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FDA to Hold Part 15 Hearing on Social Media and Pharma – Finally!
This is nothing less than astounding. The FDA is seeking input on social media and pharma. The hearing will be held on November 12 and 13 in Washington DC. Details are here. I have often railed against the DDMAC … Continue reading
Posted in FDA Policy, New and Social Media
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Weekly Roundup – 9-18-09
Well, now that the summer is over and Congress is back from their "recess" I decided it was time to bring back the Weekly Roundup as there is more happening in DC than usual and I'm more back in the … Continue reading
Posted in Weekly Roundup
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Update on FDA Transparency
Back in July, in response to the formation of the FDA's Transparency Task Force, I wrote a posting called "When Transparency is Easy – Advisory Committee Transparency". The point made was that while it used to be quite easy to … Continue reading
Posted in FDA Image
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