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: February 2015
Eye on FDA’s 9th Birthday
It is hard to believe, but today – February 9, 2015 – I have passed the ninth marker of Eye on FDA. It seems like only a short time ago that I was reading a friend’s excellent and humorous blog … Continue reading
Posted in Miscellaney Comments Off on Eye on FDA’s 9th Birthday
Goodbye Dr. Hamburg
In lieu of the Weekly Roundup this week, the report is dedicated to a sole development – the announcement by Dr. Margaret Hamburg of her departure from FDA after six years as FDA Commissioner. She leaves behind a number of … Continue reading
Posted in FDA Image Comments Off on Goodbye Dr. Hamburg
How We Communicate Matters – Comparing Communications Vehicles and Regulatory Enforcement
One of the benefits of tracking the regulatory actions of FDA through the Office of Prescription Drug Promotion (OPDP) is that it allows you to take the information and view it from different perspectives to look for interesting lessons and … Continue reading
Posted in Warning Letters Comments Off on How We Communicate Matters – Comparing Communications Vehicles and Regulatory Enforcement
FDA’s Novel Year of Novel Drug Approvals – 2014
Of course it is more than a roll of the dice. A lot of work and effort goes into medical treatment applications for approval and into evaluating them for consideration. As was widely discussed in FDA-watching circles, the agency approved … Continue reading
Posted in FDA Image, FDA Policy Comments Off on FDA’s Novel Year of Novel Drug Approvals – 2014