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 2008
FDA Documents on Cloning Available
FDA documents on cloning are now available. You can view the Animal Cloning Risk Assessment. The Risk Management Plan for Animals and Their Progeny. The Guidance for Industry on Cloning. For questions regarding this guidance, contact Larisa Rudenko, Center for … Continue reading
Posted in FDA Policy, Food
2 Comments
What is a Cholesterol Patient to Think?
I have very high cholesterol. I don’t even want to tell you how high. But I am also a bit of a statin-phobe. So when my doctor prescribed Vytorin, despite the extremely attractive direct-to-consumer advertising, I resisted. Vytorin is a … Continue reading
Posted in Crisis Communications
4 Comments
Food from Cloned Animals, Ok by Europe, FDA
This week the European Food Safety Authority launched its draft on food from cloned animals, opening it for public comment. They have also posted their draft opinion on the safety of food from cloned animals. Today, the Washington Post carries … Continue reading
Posted in FDA Policy, Food
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Begin Communications Earlier in the Drug Review Process
One of the many lessons available from the track record of the FDA last year involves communications and preparation for advisory committee and FDA approvals. There increasing numbers of approvable letters than there were declines in approvals last year. There … Continue reading
Posted in Advisory Committee Prepapartion
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Weekly Roundup – 1/11/08
Well, this is the first Weekly Roundup of the new year – and an exciting year it has been. Since closing out the Where Do the Candidates Stand series, several have dropped out, and there have been surprises. Notably, Senator … Continue reading
Posted in Weekly Roundup
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