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: January 2011
Weekly Roundup 1/7/11
Happy New Year. Though it is one of those weeks that is always tinged with a little sadness, isn’t it? The Christmas trees, once adorned and adored, lie like derelicts along side roads or at the curb in haunting darkness … Continue reading
Posted in Uncategorized
2 Comments
Dr. Sharfstein’s Departure
This week, the news came out, ironically via Twitter, that Dr. Joshua Sharfstein was going to be departing as Deputy Commissioner from the FDA, effective almost immediately, to take on duties at the state level in Maryland. When he and … Continue reading
Posted in Uncategorized
2 Comments
Pharma TWANK (Twitter Rankings) 2011
TWANK. I made it up. Stands for Twitter Ranking. Just before Christmas, I wrote a post that reviewed pharma YouTube channels and assessed how they are doing. There, for the most part, it did not seem that the industry has … Continue reading
Posted in New and Social Media
15 Comments
FDA AdComm Calendar for 2011 – Where is the Action?
At nearly the end of 2010, the FDA published the tentative calendar for advisory committee meetings for 2011. Naturally, the agency cannot precisely detail the calendar at this stage, but it does provide a bit of a signal regardomg the … Continue reading
Things to Look for in 2011
Well, everyone is either doing their look-back or look-forward thing. The future is more interesting than the past, so here is the Eye on FDA list of things to look for this year: Oversight, Oversight, Oversight – The FDA never … Continue reading
Posted in FDA Policy
Comments Off on Things to Look for in 2011