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: December 2007
Ron Paul – Where do the Candidates Stand – Part 10
Ron Paul is widely considered to be a libertarian and one sees that reflected in many aspects of his campaign site, though it is not entirely true of his outlook on healthcare. Take, for example, his outlook on the rights … Continue reading
Posted in Current Affairs
1 Comment
Weekly Roundup – 12/14/07
The Midwest and Northeast have been pounded by ice storms and Nor’easters. Here in the Mid-Atlantic, there has been much gloom, both figuratively and literally. The last of the debates among the candidates before the Iowa Caucuses were held this … Continue reading
Posted in Weekly Roundup
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Chalk Up Yet Another Multiple Approvable Letter – This Time for Neurocrine
Neurocrine Biosciences has announced that they received a second approvable letter from the FDA for their product indiplon for the treatment of insomnia. According to the company release: On May 15, 2006, the Company received an action letter from the … Continue reading
Posted in FDA Policy
1 Comment
Barack Obama – Where the Candidates Stand – Part 9
Barack to the Future! That was a campaign slogan I thought of quite some time ago, I can’t imagine why the campaign hasn’t recruited me! The Obama plan addresses the needs for greater insurance coverage among Americans, but he also … Continue reading
Posted in Current Affairs
1 Comment
India Grants Patent to AIDS Drug
One of the many confounding things about the AIDS epidemic is the radical shift of the HIV disease burden to populations of countries with the least ability to payfor therapy. That creates a number of dilemmas and conundrums. One, those … Continue reading
Posted in Marketing
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