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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Daily Archives: December 10, 2007
Approvable Letter Issued to GSK for Requip® (ropinirole) XL™
In what has to be a rec0rd-setting year for approvable letters, GlaxoSmithKline for Requip® (ropinirole) XL™ for the treatment of Parkinson’s Disease has received an approvable letter from the FDA. According to the press release issued by GSK today, "this … Continue reading
Posted in FDA Policy
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John McCain – Where the Candidates Stand – Part 8
The focus of the McCain position on health care is not on universal coverage, but on the control of costs through a number of mechanisms. In a speech in October, 2007 in Iowa, he stated that "[t]he state of our … Continue reading
Posted in Current Affairs
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