Daily Archives: June 11, 2014

Warning and Untitled Letters By Therapeutic Category – Oncology

Posted on June 11, 2014 by Mark Senak

Ever since developing a data base on the Office of Prescription Drug Promotion (OPDP) Warning and Untitled letters, I have wanted to sort the information along various lines to see differences and similarities given different circumstances. Last year, I produced … 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: June 11, 2014

Warning and Untitled Letters By Therapeutic Category – Oncology

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