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.
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Daily Archives: July 28, 2008
Eisai Gets Thumbs Down Action Letter
Another action from the FDA today that gives a thumbs down to an investigational drug. Today Eisai announced that it had received a non-approvable letter for the investigational compound fospropofol disodium injection which has been in review at the FDA … Continue reading
Posted in Uncategorized 5 Comments
A Not Approvable Letter That Outlines What is Necessary for Approval
This morning, Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced receipt of a not approvable letter from the FDA for iloperidone, an investigational atypical antipsychotic that was reviewed for the treatment of schizophrenia. It is noteworthy on a few fronts. First, it … Continue reading
Posted in Approvable Letters 1 Comment