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: January 2013
Upcoming AdComm Topics
Earlier this month, I put up the schedule for the dates that FDA has scheduled for advisory committees for the year to give some limited as it provides a little insight into what can be expected in the way of … Continue reading
Posted in Advisory Committee Prepapartion Comments Off on Upcoming AdComm Topics
Election Impact – The New Class
Around elections, I have usually tried to provide some insight into where candidates stood on health care related issues, particularly affecting the development and marketing of medical products. I wasn’t able to do that through this election cycle, but now … Continue reading
Posted in Current Affairs, Legislation 1 Comment
FDA’s AdComm Schedule for 2013
Happy New Year everyone. Usually by the end of the year, FDA publishes a tentative calendar for Advisory Committee meetings to be held for the upcoming year, however it appears that the calendar was just published today in the Federal … Continue reading
Posted in Advisory Committee Prepapartion Comments Off on FDA’s AdComm Schedule for 2013