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 2011
Weekly Roundup 12-16-11
Two weeks before the year’s end – gifts are not yet bought much less wrapped. Cards not addressed because they likewise have not been purchased. Desperation and panic are tugging at my consciousness. And so let’s round up stuff from … Continue reading
Posted in Weekly Roundup 2 Comments
Weekly Roundup – 12-9-11
The last of the leaves are being picked up. The trees are nearly bare. The Thanksgiving leftovers are long gone and there are the cards to address and send and the shopping to be done and the next set of … Continue reading
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HHS Secretary Directs FDA Decision on Plan B
Plan B oral contraceptive (levonorgestrel 1.5mg), commonly known as the “morning after” pill, has been available for women over 17 for several years without a prescription. The eventual granting of non-prescription status followed a long and somewhat tortured regulatory pathway … Continue reading
Posted in Approval Announcements, FDA Policy Comments Off on HHS Secretary Directs FDA Decision on Plan B