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: January 2009
What Would Congress Do? – A Conversation With Dick Gephardt
There is a lot of change going on. Driving past the mall today, one could see lines of tents being erected on the mall. I recently took a photo while walking past the Capitol of the scaffolding as it was … Continue reading
Posted in Podcast
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Public Affairs Increasingly Digital – Congress Hits YouTube
Over time, it has been important to note when there have been advances by public affairs into the digital realm, such as when the Clerk of the U.S. House began to Twitter. In fact, nothing so much as says "grass … Continue reading
Posted in New and Social Media
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Complete Response Letter Review for December 2008
"Complete Response Letter" is a kind of funny term. It implies finality when in fact, the outcome means that there is more to do. During December, a number of companies got their marching orders from the FDA. Here is a … Continue reading
Posted in Complete Response Letters
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A Conversation with the FDA About the Nature of REMS
In 2007, the Food and Drug Administration Amendments Act (FDAAA) was signed into law by President Bush. The legislation contained a great deal of reform of FDA regulation over the pharmaceutical and biotech industries, one element of which was … Continue reading
Posted in FDA Policy, Risk Management
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British Medical Journal Expands Digital Footprint with New YouTube Channel
In what is a growing tide of movement by healthcare into the YouTube space, last month the presigious British Medical Journal (BMJ) started its own YouTube channel called BMJmedia and moving ahead of other important journals such as the Journal of … Continue reading
Posted in New and Social Media
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