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: December 2010
Happy 2011
Hello! I had intended to post this last week of 2010 but was decked by a nasty flu that hit me on Christmas. So instead, I am trying to recoup my energies instead for 2011. Hopefully you have had a … Continue reading
Posted in Uncategorized
Comments Off on Happy 2011
Weekly Roundup 12/24/10
Actually, I’m going to step away from the usual Weekly Roundup format to look at our stocking. Is the stocking empty, or is there something rattling around it yet to come? For those whose priority was to receive the FDA … Continue reading
Posted in Weekly Roundup
Comments Off on Weekly Roundup 12/24/10
Commentary on FDA and Social Media Guidance
A lot has been said among the community of people who work in medical product communications about the news released here evening before yesterday that the FDA would not be meeting its target for releasing a draft guidance on social … Continue reading
Posted in FDA Policy, New and Social Media
4 Comments
Breaking – Its Official – FDA Delaying Social Media Guidance Until at Least Q1 2011
In March 2009, the FDA stated its first outlines for its approach to the regulation of social media and the Internet with a podcast with Jean Ah-Kang at the Division of Drug Marketing, Advertising and Communications that said it was … Continue reading
Posted in New and Social Media
28 Comments
YouTube By the Numbers – Pharma Channels and Rankings
Recently I wrote about the fact that I didn’t think that overall the pharma sector was doing a very good job on the YouTube front. YouTube is a tough medium. Like a blog, it takes upkeep and one has to … Continue reading
Posted in New and Social Media
7 Comments