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 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.
Posts by Date
Monthly Archives: January 2008
FDA documents on cloning are now available. You can view the Animal Cloning Risk Assessment. The Risk Management Plan for Animals and Their Progeny. The Guidance for Industry on Cloning. For questions regarding this guidance, contact Larisa Rudenko, Center for … Continue reading
I have very high cholesterol. I don’t even want to tell you how high. But I am also a bit of a statin-phobe. So when my doctor prescribed Vytorin, despite the extremely attractive direct-to-consumer advertising, I resisted. Vytorin is a … Continue reading
This week the European Food Safety Authority launched its draft on food from cloned animals, opening it for public comment. They have also posted their draft opinion on the safety of food from cloned animals. Today, the Washington Post carries … Continue reading
One of the many lessons available from the track record of the FDA last year involves communications and preparation for advisory committee and FDA approvals. There increasing numbers of approvable letters than there were declines in approvals last year. There … Continue reading