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.
Category Archives: Crisis Communications
Webinar – This is Not a Drill – Communications in the New Pandemic
Tomorrow at noon my employer will be holding a Webinar with the above title featuring myself, Jeff Levi of Trust for America's Health, and my colleague Christina Pearson, former Deputy HHS Secretary for Public Affairs. How To Register System … Continue reading
Posted in Crisis Communications
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This is Not a Drill – What the Mexican Swine Flu Outbreak Means for Public Health and the Pharma Industry
For many years now, public health officials have been watching with worry for signs that the Avian flu virus might leap from birds to humans and become transmissible in a way that brings the onset of a flu pandemic not … Continue reading
Posted in Crisis Communications, Current Affairs
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The Widget Gadget from FDA
In the Weekly Roundup this week there was a bit on the nifty widget that the FDA has produced to track products recalled in the unending peanut recall. It was a mistake not to include the widget itself – here … Continue reading
Posted in Crisis Communications, FDA Image, New and Social Media
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FDA Presentation on Responses to 483s
What? What is a 483? A 483 is the vernacular for an FDA inspection of quality standards, manufacturing or the conduct of a clinical trial, and the discovery of deficiencies therein. In other words, theygo through your manufacturing facility, for … Continue reading
Posted in Crisis Communications, Useful Resources
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Transitioning to a New Communications Era
Much has been written about the reluctance of the pharmaceutical industry to become very involved in new media, both here and elsewhere. But as communications in the Internet expands and unfolds, there are newer tools available and the way in … Continue reading