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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Category Archives: Risk Management
In 2007, the Food and Drug Administration Amendments Act (FDAAA) was signed into law by President Bush. The legislation contained a great deal of reform of FDA regulation over the pharmaceutical and biotech industries, one element of which was … Continue reading
FDA Requests Cephalon to Enhance Risk Mitigation Strategies Consistent with Company’s Recommendations
This is not exactly under the headline of news – a Complete Response Letter (CRL) was issued to Cephalon on the 15th of September for its supplemental New Drug Application (sNDA) for FENTORA(R) (fentanyl buccal tablet) [C-II] as a treatment … Continue reading
The FDA announced on Friday that the drug Zelnorm, manufactured by Novartis, would be returning to market for the treatment of women with irritable bowel syndrome (IBS) for certain patients only. "These patients must meet strict criteria and have no … Continue reading
Last week, the FDA announced the formation of a new Risk Communications Advisory Committee that will differ from the existing Drug Safety and Risk Management Advisory Committee, presumably by focusing solely on communication of risk. Yesterday and today, the FDA … Continue reading
The FDA is scheduled to announce today a Risk Management Workshop designed to discuss such programs and share information among key stekholders. Risk Management has been an increasing source of concentration in the post-COX-2 era. There were compounds prior to … Continue reading