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. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
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 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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Category Archives: Crisis Communications
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
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
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
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