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: September 2008
Chrome
I have to confess, I am gaga for Google. You may have noticed in the past. I just love Google. A few weeks ago, Google launched Chrome, its new Web Browser. You may ask yourself – does the world need … Continue reading
Posted in Useful Resources
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Skillfull Communication Around a Complete Response Letter by BioDelivery Sciences
Last week I wrote about how the era of Complete Response Letters (CRLs) with which CDER has replaced "Approvable Letters and "Not Approvable" Letters opens up some new communications challenges for those working in or on behalf of a company … Continue reading
Posted in Uncategorized
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Johnson & Johnson Posts Vid Series on ADHD
As frequently mentioned, Johnson & Johnson’s YouTube presence seems more defined and certainly more active than either Abbott or GSK. They now have a total of 37 vids. Yesterday, they posted a series on ADHD which I’m including below and … Continue reading
Posted in New and Social Media
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FDA to Post Quarterly Report of Potential Safety Issues
There are few better ways to bury news than to send out a release on Friday afternoon. The FDA announced this past Friday afternoon that it would begin to post potential safety issues on the Internet. There are those who … Continue reading
Posted in Drug Safety, FDA Policy
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A Conversation with Dr. David Acheson, Assistant Commissioner at FDA – Anatomy of the Salmonella Crisis from this Summer
Something very good happened and something kinda bad for me yesterday. The good part is that I had the opportunity to sit down again with Dr. David Acheson, Assistant Commissioner for the FDA in charge of Food Safety. The bad … Continue reading
Posted in Food
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