About the AuthorMy name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in Washington D.C. 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.
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 BlogEye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. 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: April 2016
Goodbye April. It was nice knowing you. There were a lot of noteworthy developments this week and I would like to write about them all, but as usual, will pick only a few from the bunch. FDA Issues Complete Response … Continue reading
A few weeks ago it was snow, now it is pollen – laden everywhere. Dogs, cars, outdoor seating, all covered in a fine yellow haze. Or is that me? I have had such a busy week that the result has … Continue reading
It seems safe to say we are officially done with snow. Winter is finally at our backs. In the rear view mirror. Yes, we have shifted gears into that very, very short time of the spring – at least here … Continue reading
Election cycle aside, it is going to be a rough summer. As things stand, this will likely become the summer of Zika as the country faces a growing potential for dealing with transmission inside the U.S. and abroad. As the … Continue reading