Daily Archives: July 28, 2008

Eisai Gets Thumbs Down Action Letter

Posted on July 28, 2008 by Mark Senak

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

Posted on July 28, 2008 by Mark Senak

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

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.
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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!
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Eye 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.
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Daily Archives: July 28, 2008

Eisai Gets Thumbs Down Action Letter

A Not Approvable Letter That Outlines What is Necessary for Approval

About the Author

Stay Connected

My Profile

About This Blog

Posts by Date

My Favorite Dogs

Twitter List

Legislative Tracking Tools

RSS

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