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: October 2007
Yesterday the FDA announced a new drug approval for the treatment of HIV. Bucking the FDA’s recent inclination to approvable letters, the approval of Isentress (raltegravir) brings a first-in-class treatment known as integrase strand transfer inhibitors to the armentarium of … Continue reading
Following last week’s chart displaying the quantitative overview of FDA’s DDMAC issuance of Warning Letters and Untitled Letters, I wanted to begin this week with a qualitative perspective on what those letters covered. Since there are so few letters, it … Continue reading
Here is a brief update on the pattern of Warning Letters issued by DDMAC to companies for violations in promotion. As you can see, the numbers under the Bush Administration have seriously declined, as pointed out frequently here on this … Continue reading
Well, autumn inside the nation’s first-city is getting off to a difficult start, made more so by a complete lack of rain that makes it look as if they only autumn color is going to be brown. One can’t even … Continue reading
The newly passed legislation in Congress that will reform FDA and reauthorize the Prescription Drug User Fee Act for another five years is just one example of dynamic change that is occurring in the marketplace. This week, I was able … Continue reading