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: April 2014
Mind and Heart
The Washington Post recently carried an article regarding an investigative compound being studied for the treatment of Duchenne muscular dystrophy which affects young boys – a condition for which there is no current treatment. The course of the condition means … Continue reading
Posted in FDA Policy Comments Off on Mind and Heart
Weekly Roundup – 4.25.14
It has been one of those weeks where each day I felt it was supposed to be the day after. Monday I thought was Tuesday, Tuesday, Wednesday and so on. Here at last, I think, is Friday – the real … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 4.25.14
Upcoming AdComms by Subject Matter
In prior years, near the end of a calendar year, FDA would put up a schedule of Tentative Advisory Committee Meetings with tentative meeting dates scheduled for each Advisory Committee. This year, however, the calendar went up, but very few … Continue reading
Posted in Advisory Committee Prepapartion Comments Off on Upcoming AdComms by Subject Matter
Warning and NOV Letter Summary – 1st Quarter 2014
Each quarter, I provide an overview of the most recent Warning and NOV letters from OPDP to gain insight into any lessons learned and to look at overall trends. But this quarter, it is really slim pickings. More than slim … Continue reading
Posted in Warning Letters 1 Comment
Weekly Roundup – 4.18.14
There were audible gasps all over the Internet from people experiencing yet more snow this week – the week of Easter break for many. Freeze warnings here threatened my young herbs planted only a few days before over a warm … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 4.18.14