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: September 2010
Insight into FDA’s Thinking on a Biosimilar Regulatory Pathway?
Today Teva Pharmaceuticals announced the receipt of a Complete Response Letter from the FDA for their Biological Licence Application (BLA) for Neutroval. Neutroval is a treatment to reduce the duration of severe neutropenia and the incidence of febrile neutropenia in … Continue reading
Posted in Biologics 2 Comments
The Senate Weighing in on FDA Decisions Says No to GE Salmon
There has never been a shyness on the part of members of Congress from weighing in when it comes to FDA examination of a scientific issue. That is unfortunate. Food Safety News reports (along with The Hill) that eleven U.S. Senators … Continue reading
Posted in FDA Policy, Food Comments Off on The Senate Weighing in on FDA Decisions Says No to GE Salmon
Weekly Roundup – 9-24-10
Autumn clicked into place on the calendar early in the week and we were tempted to breathe a sigh of relief, though that would have been silly. Today the temperature is supposed to top 95 degrees. We shall wait until … Continue reading
Posted in Uncategorized Comments Off on Weekly Roundup – 9-24-10
The First Amendment, Medical Products, and Regulation of Social Media
During the second day of the Food and Drug Law Institute Conference on Advertising and Promotion (#FDLIAP), I participated on a panel to discuss the First Amendment and the Regulation of Commercial speech. The panel was made up of a … Continue reading
Posted in Uncategorized 1 Comment
FDA Must Change Method for Regulating Social Media
I am at Day 2 of the Food and Drug Law Institute Advertising and Promotion Conference being held in Washington, D.C. (#FDLIAP) Yesterday, there were a couple of presentations made by the Division of Drug Marketing, Advertising, and Communications (DDMAC) … Continue reading
Posted in Uncategorized Comments Off on FDA Must Change Method for Regulating Social Media