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.
Posts by Date
Legislative Tracking Tools
Monthly Archives: September 2014
Weekly Roundup 9.26.14
I bring you the Weekly Roundup today from Cape Cod where there is a lovely sense of autumn in the air, but blue skies and lovely shoreline allowing us to still remember the summer’s most pleasant days. And here is … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 9.26.14
Here Comes the Sun – Communications Tips on The Sunshine Data Publication
The Sunshine Act will peek out from behind some, but not all, of the clouds on the horizon soon, leading to a new day in transparency on payments between the medical products industry and those who provide care. Data will … Continue reading
Posted in FDA Policy, Miscellaney Comments Off on Here Comes the Sun – Communications Tips on The Sunshine Data Publication
Weekly Roundup 9.19.14
Argh! It is International Talk Like a Pirate Day! Fear not Matey! I’m not gonna write my whole posting in pirate-speak, though it be a tempting morsel to ponder. There were lots of approvals this week and finally a wee … Continue reading
Posted in Weekly Roundup 1 Comment
Weekly Roundup 9.5.14
After a surprisingly mild August, September begins with summer in full force – heat, humidity and a mosquito rally that is immensely annoying. Forecasts however predict that we only have one more day of this and then a break to … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 9.5.14