Monthly Archives: July 2007

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 | 1 Comment

Weekly Roundup – 7/27/07

Well, another week gone by.  Congress is in the throes of things with the White House.  But otherwise, it has not been the kind of hot, humid summer we are used to here in Washington.  And yet still, it has … Continue reading

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Approvable Letter Mania

I am beginning to believe that there have been a flood of approvable letters, though I haven’t gone back over the years to count the rate – but my gut tells me that the rate has increased.  It is a … Continue reading

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GSK – Again Pushing the Envelope

Last week I wrote about GSK’s alli blog – a blog dedicated to marketing an OTC product.  This week, GSK again drew attention in the marketing world by developing a campaign that raises awareness of genital herpes among African Americans.  … Continue reading

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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

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