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. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.Stay Connected
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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 New York 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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Monthly Archives: April 2012
FDA Sends Out 10 Warning Letters to Dietary Supplement Manufacturers
10 Count ’em 10. That is how many Warning Letters the agency sent out last Friday to manufacturers and distributors of dietary supplements. The specific focus of the letters was products that were being marketed containing dimethylamylamine, also known as … Continue reading
Posted in Warning Letters
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Weekly Roundup – 4/27/12 – Back in the Saddle
Lately I have been on hiatus. It was not a planned one, but brought on by a convergence of circumstances that I’m happy to say includes being extremely busy. That said, I have missed writing my postings and have stored … Continue reading
Posted in Weekly Roundup
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Seeking Transparency on Sunshine Act
Yesterday Senators Kohl and Grassley submitted a letter to CMS seeking information on the implementation of the Sunshine Act – the legislation passed and signed into law that would put into place a system for public reporting of the financial … Continue reading
Posted in Industry Image
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