About the AuthorMy 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.
My ProfileI 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 BlogEye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. 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
Monthly Archives: September 2007
The week is at a close. So is September. And, a week’s vacation for me at Cape Hatteras also comes to an end. It was nice, but I’ve had to rely on dial-up, which has made posting to the blog … Continue reading
An approvable letter was issued by the FDA to Alcon for Retaane 15 mg for the treatment of wet-aged macular degeneration (AMD). Approvable letters are issued when the FDA acknowledges that it is inclined to approval given certain conditions to … Continue reading
I was fascinated to read the RPM Report analysis of the new system that will emerge when the new FDA bill is signed into law. A new user fee program for review of DTC ads will exist that allows the … Continue reading
As mentioned last week, compromise legislation passed that is bringing a 5-year extension of PDUFA is also bringing with it a codification on reducing real or perceived conflict of interest rules for members of FDA advisory committees. The legislation sets … Continue reading