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: February 2015
Weekly Roundup 2.27.15
Another round of snow this week, perhaps the last gasp of winter? I can’t say there is any hint of Spring in the air in these parts, but sure hope there is where you are. In any event, I am … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 2.27.15
Legislative Proposals in the 114th Congress
Every so often, EyeonFDA has an update for you on legislation that is proposed in the Congress that would impact the medical product marketplace if passed. The new Congress has just two months old and while the last Congress was … Continue reading
Posted in Legislation Comments Off on Legislative Proposals in the 114th Congress
Weekly Roundup 2.20.15
Friiiiiiggggggiiiiiiiddddd. I realize anyone who doesn’t live in the Northeast can’t really complain, but winter finally woke up in the capital of our nation. Last week I took a picture of green daffodil sprouts coming up from the grounds of … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 2.20.15
The Language of Risk – FDA’s Evolution of Thought
How does the average patient assess the risk of a medical product when deciding whether or not to seek it out? This month, FDA released a new draft guidance document entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk … Continue reading
Posted in FDA Policy Comments Off on The Language of Risk – FDA’s Evolution of Thought
Weekly Roundup 2.13.15
Happy Friday the 13th and the day before Valentine’s Day. It is cold. There is fierce wind. Boston is due more snow. As if there aren’t enough reasons to dislike February…. For me the week flew by and I hope … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 2.13.15