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

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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

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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 | Comments Off

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

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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

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