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: May 2007
Risk Management Workshop
The FDA is scheduled to announce today a Risk Management Workshop designed to discuss such programs and share information among key stekholders. Risk Management has been an increasing source of concentration in the post-COX-2 era. There were compounds prior to … Continue reading
Posted in Drug Safety, Risk Management
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Congressional Hearing on FDA’s Handling of Avandia
I don’t know what the record is for announcing a Congressional investigation after breaking news, but the title may go to Congressman Henry Waxman (D-CA), under whose feet no grass grows. I think he may hold the record. There has … Continue reading
Posted in Drug Safety, FDA Image, Industry Image
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Supplements and Adverse Event Reporting – A Conversation with the Council for Responsible Nutrition
As reported in the past here, the 109th Congress passed S.3546 – The Dietary and Supplement Non-Prescription Drug Consumer Act – legislation that would make it mandatory for manufacturers of dietary supplements and OTC products to report serious adverse events. … Continue reading
Posted in Podcast
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Weekend Approvable Letters
Sometimes the FDA sends action letters to companies late on Friday. When it is an approval letter, that can be unfortunate, as companies have the unenviable task of either holding the news until Monday or announcing it to a lackluster … Continue reading
Posted in Approvable Letters
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Weekly Roundup – 5-18-07
The weather has been beautiful here inside the Beltway. We are already on the cusp of summer and in a few weeks, we will have Memorial Day and we can break out our summer whites! USDA Clears Swine for Food … Continue reading
Posted in Weekly Roundup
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