Monthly Archives: March 2014

Weekly Roundup 3.28.14

Posted on March 28, 2014 by Mark Senak

You know I’m busy when I don’t even have time for the Weekly Roundup. I have had a very heavy travel schedule and a workload that has been quite a heavy one. And sadly, there is no letup in sight … Continue reading →

Posted in Weekly Roundup | Comments Off

Weekly Roundup 3.14.14

Posted on March 14, 2014 by Mark Senak

The nation is on the lookout for Spring. And so am I. Despite the harsh, harsh and cold winds of this week, and the redundant snowfall last week, there nevertheless appear daffodil buds above the dirt, some quite robust in … Continue reading →

Posted in Weekly Roundup | Comments Off

OPDP Issues Untitled Letter Involving Social Media

Posted on March 12, 2014 by Mark Senak

Sort of. There is, of course, a difference between a regulatory action letter that is issued because of a social media use and a regulatory action letter that is issued the communication happens to involve a social media platform. In … Continue reading →

Posted in Social Media, Warning Letters | 1 Comment

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

Subscribe

* indicates required

Email Address *
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
March 2014

M T W T F S S

1 2

3 4 5 6 7 8 9

10 11 12 13 14 15 16

17 18 19 20 21 22 23

24 25 26 27 28 29 30

31

« Feb Apr »
Twitter List
Legislative Tracking Tools