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 2014
Weekly Roundup 1.31.14
It will be groundhog day this coming week. I know I will be watching to see what is predicted because I, for one, am done with the cold nature of this surly winter. Dog walks have been painful. Cars everywhere … Continue reading
Posted in Weekly Roundup
Comments Off on Weekly Roundup 1.31.14
Weekly Roundup – 1.24.14
Many regular readers might remember last September when I was able to share the news that a friend had named a new born calf after me – Marky! Well, Marky is growing up and here she is – pictured behind … Continue reading
Posted in Weekly Roundup
Comments Off on Weekly Roundup – 1.24.14
Looking Back Down the Road – What Have We Learned from FDA on Regulation of Digital Media?
So last week there was a lot of interest and commentary on the issuance of a draft guidance by FDA that provided some insight into how the agency is regulating promotional speech and social media platforms. It seemed like a … Continue reading
Posted in FDA Policy, Social Media
1 Comment
Weekly Roundup 1.17.14
Two full weeks back in the saddle and I’m ready for a three day weekend. I’m late today with the Weekly Roundup, and there isn’t a lot of news to digest, but here are a few things that came out … Continue reading
Posted in Weekly Roundup
Comments Off on Weekly Roundup 1.17.14
FDA Reveals More Thinking on Social Media
Don’t judge a book by its cover – or in this case, title. In November 2009, FDA held a two-day public meeting on the Promotion of FDA-Regulated Medical Products Using the Internet and Social Media to collect input for the … Continue reading
Posted in Social Media
3 Comments