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.
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 BlogEye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. 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: April 2010
It has been one busy week, not only for me personally (cross country biz travel) but on the FDA side of things as well. Makes no sense to do anything but get started. Dendreon's Provenge Finally Gets Approval – In … Continue reading
In June of 2008, January of 2009 and again in June 2009 the General Accounting Office issued reports on the FDA and its oversight of medical devices. The June 2009 report echoed findings from the earlier January report, put forth a recommendation … Continue reading
No kidding. I mean it. Transparency is one of those buzz words that doesn't really mean much to people, because it means so many things to so many people. As a result, in some ways, the word has lost its … Continue reading
In the United States, new medicines are considered for approval by various consultant committees that the FDA uses to help assess an application for approval. In the European Union, human medicines are considered for approval by the European Medicines Agency … Continue reading