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.
Monthly Archives: April 2011
Warning and NOV Letter Summary – First Quarter 2011
For a while it seemed that FDA’s DDMAC was raising the enforcement bar. During the Bush years, enforcement plummeted from previous years dramatically. In 2008, the numbers seemed to rise, though in 2009, the numbers were actually a bit thrown … Continue reading
Posted in Warning Letters
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Advisory Committees – The Missing Links and The Vacancies
Every so often, I check in to see how the agency is faring when it comes to Advisory Committee transparency. The last time I did a chart like this several months ago, CDER and CBER figured in for having about … Continue reading
Posted in Advisory Committee Prepapartion, FDA Policy
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Weekly Roundup – 4/8/11
The nation has been served up a whole dish of bad theater from Washington this week. The play is bad. The actors are bad. And at least one of the leads can’t keep his chorus in line, however, if the … Continue reading
Posted in Uncategorized
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Status of FDA’s Proposed Regulations on Menu Labeling – A Conversation
Last Friday, the FDA published notice about draft guidance on the issue of menu labeling in restaurants. The idea of labeling food choices in restaurants has long been a goal of those who advocate for greater education for consumers in … Continue reading
Posted in FDA Policy, Food, Podcast, Uncategorized
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The Importance of Being Twitter
Many of the primary social media platforms in use have been around for five years or more. While the television took decades after its invention in the late 1920s to achieve widespread uptake, today new media platforms emerge, have … Continue reading
Posted in New and Social Media
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