Daily Archives: May 9, 2007

Dendreon Gets Complete Response Letter

Posted on May 9, 2007 by Mark Senak

Since my last update to approvable letters, there have been several more. The latest to add to the list is the much anticipated decision regarding Dendreon’s Provenge. The company announced the receipt of a "Complete Response Letter" which is the … Continue reading →

Posted in Approvable Letters | Comments Off

More on Melamine

Posted on May 9, 2007 by Mark Senak

Last week on the first of the month, I wrote about Melamine Creep – the idea that the discovery of a foreign substance in our pet food has made its way into the feed of pigs and chickens. Now we … Continue reading →

Posted in Crisis Communications, Current Affairs | Comments Off

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: May 9, 2007

Dendreon Gets Complete Response Letter

More on Melamine

About the Author

Stay Connected

My Profile

About This Blog

Posts by Date

My Favorite Dogs

Twitter List

Legislative Tracking Tools

RSS

Books by Me