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: July 2011
Weekly Roundup 7-29-11
Goodness. The year is over half over and we are about to slip into a steamy August. The weather here in Washington, D.C. relented this week, with lower humidity and pleasant temperatures, but the frosted glass this morning indicates a … Continue reading
Posted in Weekly Roundup
Comments Off on Weekly Roundup 7-29-11
Guidance on Social Media – But Not the One You Think….
Last week the bookstore Borders announced that it would be liquidating its remaining stores. On the PBS News Hour, Jeffrey Brown spoke with Slate’s Annie Lowry about the giant chain went from having huge box bookstores to the end of … Continue reading
Posted in New and Social Media, Pricing and Value
6 Comments
Weekly Roundup 7-22-11
Egg + Sidewalk = Breakfast! There is a huge mass of hot air here in Washington, D.C., and that isn’t even speaking of the weather. But if you throw that in, it is really, really hot. The petunias look wilted … Continue reading
Posted in Weekly Roundup
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FDA Issues Draft Guidance on Medical Apps
The glacier has moved. Today the FDA announced that it was issuing a Draft Guidance on the Oversight of Medical Applications and seeking public input into the draft. For the most part, the guidance is involved with distinguishing what is … Continue reading
Posted in FDA Policy, New and Social Media
1 Comment
Financial Crisis = Public Health Crisis – FDA Funding
The mandate for protecting the public’s health at FDA has expanded dramatically, especially last year when the Food Safety Modernization Act (FSMA) was passed and signed into law, giving the FDA new authorities to inspect and initiate recalls of food … Continue reading
Posted in Uncategorized
7 Comments