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: December 2006
New Media and YOU
TIME Magazine has come out with it’s Person of the Year. It is You. Not just You, but the use of the Internet. The magazine, a print magazine, is signaling that there has been a shift in the way we … Continue reading
Posted in Current Affairs, Marketing
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Weekly Roundup – 12/15/06
The 109th "Do Nothing" Congress has called it quits. They are headed into the sunset. But before they left, there was a lot of last minute bill-passing to make up for their lack of drive during the past two years, … Continue reading
Posted in Weekly Roundup
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Anti-depressants and Labels
Yesterday, the FDA held an advisory committee meeting on the labeling of anti-depressants in adults. I was not present, but heard coverage of the meetings on National Public Radio. There was wrenching testimony by those who have lost loved ones … Continue reading
Posted in FDA Policy, Risk Management
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Expanded Access to Experimental Drugs – Applause
Back in the 1980s when the HIV epidemic was sweeping through large cities and there were few treatment options available, there was a great deal of agitation at the grassroots level for the FDA to reform the process and do … Continue reading
Posted in FDA Policy
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Adverse Events Reporting on OTCs and Supplements
As reported earlier this week, S.3546 – the Dietary and Supplement and Nonprescription Drug Consumer Act was passed by the Senate on December 6. Subsequently, on December 9, the House passed the Bill by a 2-1 majority. A few minutes … Continue reading
Posted in OTC Switches, Vitamins and Supplements
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