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 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: October 2007
The Food and Drug Administration today is scheduled to publish a Draft Guidance in the Federal Register entitled Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and DRug Administration Staff: Public Availability of Advisory … Continue reading
There are 65 days left to the Iowa Caucus. As I mentioned last week, I intend to profile the healthcare positions of each of the candidates as those positions might affect the workings of the FDA and the pharmaceutical market. … Continue reading
Tomorrow, the FDA will be publishing a Notice entitled the "User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biologic Products; Request for Notification of Participation and nUmber of Advertisements for Review" – A MOUTHFUL! … Continue reading
In July of 2000, two companies tried to take statins from RX to OTC. The first was Bristol Myers Squibb attempting to switch Pravachol and the other was Merck trying to switch Mevacor. Today, there is a Federal Register notice … Continue reading