About the AuthorMy 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.
My ProfileI 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 2007
FDA Announces Meeting on Stem Cells
The FDA has announced an upcoming meeting on stem cells. From the federal register… "On April 10, 2008, the committee will meet to discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells. On … Continue reading
Posted in FDA Policy 1 Comment
Fred Thompson – Where the Candidates Stand – Part 13
An analysis of the Fred Thompson plan is difficult because essentially he has not announced a healthcare plan. Perhaps he is waiting for a script. In any case, there is very little to tell her in that he has not … Continue reading
Posted in Uncategorized 1 Comment
Mitt Romney – Where the Candidates Stand – Part 12
Mitt Romney has attacked many of his rivals’ plans as being "socialized medicine". He recently changed his healthcare Web page on his campaign site to showcase a "plan" but it, like many of the candidates, is less a plan than … Continue reading
Posted in Current Affairs 1 Comment
Bill Richardson – Where the Candidates Stand – Part 11
The Bill Richardson healthcare plan is not as hefty as some of his Democratic colleagues, not nonetheless, covers a good bit of ground. His plan is not one that puts into place a universal healthcare approach with a new government … Continue reading
Posted in Current Affairs Comments Off on Bill Richardson – Where the Candidates Stand – Part 11
Advisory Committee Schedule for 2008
Rather late this year, the FDA has posted the tentative dates for advisory committee meetings for 2008. Right now, except for meetings that have already been announced, these are primarily "save the date" reservations so that the many experts on … Continue reading
Posted in FDA Comments Off on Advisory Committee Schedule for 2008