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
Monthly Archives: April 2010
When it comes to social media – journalists are getting confusing signs. In the last quarter of 2009, - the Bulldog Reporter/TEKgroup International 2009 Journalist Survey on Media Relations Practices surveyed over 2300 journalists and does so on an annual basis to … Continue reading
(NOTE: After the initial publication of this posting, information was sent to me regarding FDA's Guidance on Risk Information – the posting was changed to note this important update and re-published. The change is noted in italics in the third … Continue reading
Springtime abounds. I am still laid quite low by record levels of tree pollen, as I believe, are many others. I am a first time sufferer and have new respect for those who have borne life-long allergies. I see beautiful … Continue reading
What if the FDA held virtual meetings? It could get more input more often from more people for less money. What if they held virtual AdComm meetings? Wouldn't that be great? It isn't far fetched, it just requires vision. … Continue reading