About the AuthorMy 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.
My ProfileI 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 BlogEye 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: September 29, 2008
A Warning Letter was posted by CDER’s DDMAC on Friday, September 26 that was sent to Shire Pharmaceuticals regarding a Web promotion and a YouTube video for Adderall XR. While normally Warning Letters are not featured here except in a … Continue reading →
One of the many potential uses of YouTube is the ability of the medium of videos to address issues of public health. In relatively short order, any entity can put together a video and post it quite inexpensively and in … Continue reading →