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: May 2009
Weekly Roundup – 5/29/09
Oh gosh. The pollen count is off the charts. Summer storms are overanxious and overabundant. The first tropical depression has appeared off the Atlantic just prior to the official beginning of the Hurricane Season. A diabetic is ascending to the … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 5/29/09
Warning Letter Quarterly Update, Last Quarter 2008, First Quarter 2009, Part 2
Ok, last week, I ran a posting that profiled the rate of Warning and Untitled Letter rate from FDA's DDMAC, this week, let's look at the substance and see what, if any, lessons there are to be learned from DDMAC … Continue reading
Posted in Warning Letters Comments Off on Warning Letter Quarterly Update, Last Quarter 2008, First Quarter 2009, Part 2
Margaret Hamburg Gets Unanimous Senate Approval
It could be the end of an era. For many years, the FDA has lacked decisive leadership and strategic vision. The agency, which was once the gold-standard of regulatory agencies, has seen that gold tarnish overtime while it … Continue reading
Posted in FDA Image Comments Off on Margaret Hamburg Gets Unanimous Senate Approval