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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Legislative Tracking Tools
Monthly Archives: July 2007
Returning a Product to Market After it is Tossed
The FDA announced on Friday that the drug Zelnorm, manufactured by Novartis, would be returning to market for the treatment of women with irritable bowel syndrome (IBS) for certain patients only. "These patients must meet strict criteria and have no … Continue reading
Posted in Drug Safety, Risk Management 1 Comment
Weekly Roundup – 7/27/07
Well, another week gone by. Congress is in the throes of things with the White House. But otherwise, it has not been the kind of hot, humid summer we are used to here in Washington. And yet still, it has … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 7/27/07
Approvable Letter Mania
I am beginning to believe that there have been a flood of approvable letters, though I haven’t gone back over the years to count the rate – but my gut tells me that the rate has increased. It is a … Continue reading
Posted in Approvable Letters 2 Comments
GSK – Again Pushing the Envelope
Last week I wrote about GSK’s alli blog – a blog dedicated to marketing an OTC product. This week, GSK again drew attention in the marketing world by developing a campaign that raises awareness of genital herpes among African Americans. … Continue reading
Posted in Marketing Comments Off on GSK – Again Pushing the Envelope
Product Specific Advisory Committee Meeting s
Tomorrow’s Federal Register is scheduled to carry a notice of a joint meeting of the Cardiovascular and Renal Drugs Advisory Committee with the Drug Safety and Risk Management Advisory Committee to be held on September 11, 2007. The committees will … Continue reading
Posted in Drug Safety Comments Off on Product Specific Advisory Committee Meeting s