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 2010
Weekly Roundup – 4/30/10
It has been one busy week, not only for me personally (cross country biz travel) but on the FDA side of things as well. Makes no sense to do anything but get started. Dendreon's Provenge Finally Gets Approval – In … Continue reading
Posted in Weekly Roundup
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Communications and Marketing Implications of a Change in FDA Policy for Medical Device AdComms
In June of 2008, January of 2009 and again in June 2009 the General Accounting Office issued reports on the FDA and its oversight of medical devices. The June 2009 report echoed findings from the earlier January report, put forth a recommendation … Continue reading
Posted in Advisory Committee Prepapartion, FDA Policy
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FDA Pioneers New Level of Transparency – An Interview with Dr. Joshua Sharfstein
No kidding. I mean it. Transparency is one of those buzz words that doesn't really mean much to people, because it means so many things to so many people. As a result, in some ways, the word has lost its … Continue reading
Banning Access to Social Media in the Workplace – Make Sense?
This week I was in Chicago where I spoke at a meeting of the Illinois Association of Healthcare Attorneys as part of a panel of lawyers about my favorite topic – social media and healthcare. In attendance were many lawyers who … Continue reading
Posted in New and Social Media
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Advisory Committee Transparency Update – FDA and EMEA
In the United States, new medicines are considered for approval by various consultant committees that the FDA uses to help assess an application for approval. In the European Union, human medicines are considered for approval by the European Medicines Agency … Continue reading
Posted in Uncategorized
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