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 2006
It is Raining Approvable Letters
Apparently, the FDA is finishing up business for 2006 with a spate of activity. In addition to the three approvable letters noted last week, the FDA issued another approvable letter today to Nuvo Research Inc., Yahoo reports, for a topical … Continue reading
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Hiatus Interruptus – Advisory Committees Set Meeting Dates
Hi there. I know I was taking this week off for vacation, but it hasn’t worked out that way. After a quick trip to the family, a 14 hour return drive, instead of R&R, I’m working again. So here is … Continue reading
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Three Approvable Letters Issued This Week
Not all companies are getting what they want for Christmas. Taking on the form of the FDA, Santa has left a lump of coal in some corporate stockings when approvable letters were issued to three companies. Remember that receipt of … Continue reading
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Hello everyone. Eye on FDA is going on holiday hiatus for the balance of the year. We will be back in January with a few new features. Have a wonderful holiday.
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Keeping an Eye on Adverse Events
This week, the FDA updated its quarterly reporting on Adverse Events. It is a bit of a complicated mess to work your way through. But there are other ways to look at adverse events and given that there have recently … Continue reading
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