About the Author
My 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.Stay Connected
My Profile
I 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
Twitter List
Legislative Tracking Tools
Monthly Archives: February 2016
Weekly Roundup 2.19.16
There hasn’t been a Weekly Roundup for the past few weeks, but news has been slow and life has not, so apologies. It seems the shorter days of Winter make it more challenging for me to get all the things … Continue reading
This is Your State – This is Your State on Drugs
In years gone by, I have taken occasion to write a posting with this title to take a look at the policy activity that is going on at the state level that impacts medicines. It has been a few years … Continue reading
Posted in Legislation
Comments Off on This is Your State – This is Your State on Drugs
10 Years of Eye on FDA – Looking Back
This month marks a decade of Eye on FDA. A good friend of mine was writing a personal blog, which most blogs were back then, that was well-written and funny and I thought – hey I could do that only … Continue reading
Posted in Current Affairs
Comments Off on 10 Years of Eye on FDA – Looking Back
From HIV to Zika – The Role of Communications
The pathogen may change, but there are aspects of communications during a time of outbreak, particularly involving an emerging pathogen, that seem to be a constant. A few short months ago no one had ever heard of the Zika virus. … Continue reading
Posted in Current Affairs
Comments Off on From HIV to Zika – The Role of Communications
FDA Guidance Output Plans for 2016
While there has been focus on what FDA accomplished in 2015 – and there will continue to be some of that – it is also a great time to look ahead. What can we anticipate for 2016? This month several … Continue reading
Posted in FDA Policy
Comments Off on FDA Guidance Output Plans for 2016