Daily Archives: May 14, 2007

Approvable Letters – A Conversation with Myself…

Posted on May 14, 2007 by Mark Senak

I am posting a podcast which, unlike past efforts, is not an interview, but a short discussion on my take on approvable letters. What makes an approvable letter more likely than an approval letter for investigational products? While there is … Continue reading →

Posted in Approvable Letters, Podcast | 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!
About This Blog

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 14, 2007

Approvable Letters – A Conversation with Myself…

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