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: Biologics
There is a policy interest in driving the biosimilar market. Among other reasons, increasing the number of generic drugs and biosimilars on the market addresses another policy priority – having an impact on the high cost of medicine. The approval … Continue reading
The FDA has finally scheduled a public meeting to solicit input on the regulatory pathway that is being developed for the approval of biosimilars. The meeting is set for November 2-3 and will be held at FDA's facility in Silver … Continue reading
Today Teva Pharmaceuticals announced the receipt of a Complete Response Letter from the FDA for their Biological Licence Application (BLA) for Neutroval. Neutroval is a treatment to reduce the duration of severe neutropenia and the incidence of febrile neutropenia in … Continue reading
Here is a newsbreaker I think. Stem cells hold a great deal of promise in research and clinical trials are underway around the world to make that promise a reality. However, many entrepreneurial efforts have been underway to use stem … Continue reading
On the Ides of March, Genetic Engineering and Biotechnology News (GEN) published an article by Ronald A. Rader, President of the Biotechnology Information Institute that provided an overview of the product approval rate focusing solely on biologics. For a long … Continue reading