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: November 2007
John Edwards – Where the Candidates Stand – Part 4
The Iowa Caucuses are fast approaching and I want to get this series done beforehand. So today, we are looking at the healthcare plan of John Edwards. This plan is similar in nature in many ways to the Clinton plan … Continue reading
Posted in Current Affairs
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The FDA’s BTC Meeting
The FDA held an all day public meeting yesterday here in Washington to gain insight into the possibility of a Behind-the-Counter (BTC) designation for drugs. BTC would be non-prescription, but would require the intervention of a learned intermediary – i.e., … Continue reading
Posted in FDA Policy
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Chris Dodd – Where the Candidates Stand – Part 3
After wars in Iraq and Afghanistan and the issue of the increasingly faltering economy, healthcare tops the polls of issues of major concern to the electorate. Reflecting that, the Biden plan was four pages long and the Clinton plan a … Continue reading
Posted in Current Affairs
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Weekly Roundup – 11/09/07
Well, autumn is definitely here. The fireplaces have once again been lit. Thanksgiving is just around the corner. And this week, Congress discovered it had a backbone when it overrode a presidential veto for the first time. Anything can happen. … Continue reading
Posted in Weekly Roundup
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Immunogenicity and Follow-on-Biologics
This week, the FDA issued a non-approvable letter to Momenta Pharmaceuticals as outlined in a press release from the company. The approvable letter was issued to Momenta and its partner, Sandoz, Inc, which is a generics manufacturing division of Novartis. … Continue reading
Posted in Biologics
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