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 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
Legislative Tracking Tools
Monthly Archives: October 2008
Weekly Roundup – 10/31/08
The autumn colors are reaching near peak in Washington, D.C. and election fever is at its apex. By the next writing of a Weekly Roundup, we will know a lot more about the future direction of the country and of … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 10/31/08
Speaking of the Election
One of the things I noted in my talk yesterday (see below) was that the Congressional races have far greater weight on the future of the regulation by the FDA of the pharmaceutical market. For those of you as intensely … Continue reading
Posted in Current Affairs Comments Off on Speaking of the Election
Change is in the Air
Yesterday I gave a brief talk at the DTC Perspectives conference held in New Jersey called DTC in the Era of Consumer Choice. I thought I’d outline a few of my thoughts on the future of DTC here as well. … Continue reading
Posted in DTC Advertising 2 Comments
Morningstar on Healthcare Reform
Morningstar health-care analysts offer their take on the candidates’ plans and their possible effects for health-care firms.
Posted in Current Affairs Comments Off on Morningstar on Healthcare Reform
Warning Letter Summary – Third Quarter 2008, Part 2
The third quarter saw some highly unusual activity on the part of FDA’s DDMAC in terms of both content and quantity. Addressing the latter first, the FDA issued 8 letters for the quarter, which is a substantial increase for the … Continue reading
Posted in Warning Letters 1 Comment