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.
Category Archives: Drug Safety
Boehringer Ingelheim Announces Cooperation with HISOAR in China
It is poetic that following the close of the Olympics in Beijing – an event that went very well in spite of all the worries leading up to it – that Boehringer Ingelheim announces a cooperation deal with a Chinese … Continue reading
Posted in Drug Safety, Pharma Industry Image
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FDA Posts New Education Vids on Safety Alerts
The FDA posted two new vids to its YouTube account. Much more than in the past, these are very timely, having only been issued this week and the vids are up. Good job FDA! The first involves the fact that … Continue reading
Posted in Drug Safety, New and Social Media
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Warning! Warning! Warning! (Yawn)
Pursuant to the posting earlier this week which noted the rate of drug safety alerts out of the FDA, there also this week was a story published at CNNMoney.com that raises the very valid question whether or not patients and … Continue reading
Posted in Drug Safety, FDA Policy
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Returning a Product to Market After it is Tossed
The FDA announced on Friday that the drug Zelnorm, manufactured by Novartis, would be returning to market for the treatment of women with irritable bowel syndrome (IBS) for certain patients only. "These patients must meet strict criteria and have no … Continue reading
Posted in Drug Safety, Risk Management
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Product Specific Advisory Committee Meeting s
Tomorrow’s Federal Register is scheduled to carry a notice of a joint meeting of the Cardiovascular and Renal Drugs Advisory Committee with the Drug Safety and Risk Management Advisory Committee to be held on September 11, 2007. The committees will … Continue reading
Posted in Drug Safety
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