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: October 2013
Final Guidance on Medical Apps
In July 2011, FDA issued a draft guidance on Medical Apps that set out the agency’s approach to regulate apps – even as thousands of such apps were being developed and downloaded by users. Just over two years later in … Continue reading
Posted in Medical Apps Comments Off on Final Guidance on Medical Apps
Weekly Roundup – 10-4-13
What’s to round up during a week when there is a government shut-down and most FDA staff are off? Well, not much, but I will go over a little and provide some thoughts about next week. But first, remember a … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 10-4-13
Keeping an Eye on FDA When There is No FDA
It would seem like an obvious challenge to write for a blog called Eye on FDA when in fact, there is a government shutdown. That said, an agency that regulates one-quarter of the U.S. economy does not come to a … Continue reading
Posted in Current Affairs Comments Off on Keeping an Eye on FDA When There is No FDA