Daily Archives: May 15, 2012

Warning and NOV Letter Summary – 1st Quarter 2012

Posted on May 15, 2012 by Mark Senak

Another quarter has zoomed by. And with it, FDA’s Office of Prescription Drug Promotion (OPDP), formerly known as the Division of Drug Marketing, Advertising and Communications (DDMAC), has issued a stream of regulatory action letters known as Notice of Violation … Continue reading →

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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 15, 2012

Warning and NOV Letter Summary – 1st Quarter 2012

About the Author

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