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.
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Monthly Archives: December 2008
This is that time off year when we look back and take stock and look forward with resolution to doing things different, as if it is always a matter of choice. The events of 2008 have been breathtaking and a … Continue reading
Ferring Pharmaceuticals is having a good month and have gotten two significant Holiday gifts, as do patients with prostate cancer. Last week, the CHMP announced approval of Ferring Pharmaceutical's new treatment for prostate cancer, Degelarix. Today, the FDA followed suit … Continue reading
I took last week off for the holidays. Expecting guests, planning menus and my other regular duties left no time for posting and I suspected, little time for others to be reading. However, in spite of the holidays, things did … Continue reading
The holiday last rush is on. I'm late with the Weekly Roundup because wrapping gifts took precedence. Traffic is sadistic. The weather, unpredictable. The guests are on the road and on their way here, and there are still menus to … Continue reading
FDA Announces New Recommendations on Evaluating Cardiovascular Risk in Drugs Intended to Treat Type 2 Diabetes
Cardiovascular risk associated with diabetes has been a major issue for those developing medications for diabetics. Yesterday, the FDA issued a press release about new diabetes drug development guidelines that the agency is issuing in relation to the evaluation of … Continue reading