Monthly Archives: May 2007

Weekly Roundup – 06/01/07

Sorry no posting yesterday, bad week. And oh dear.   Who can believe it?  It is already June of 2007.  Today every time I went to write the date today I wrote it as 2005.  What’s that about?  It could have … Continue reading

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The Senators, the FDA, the Company and The Access to Medicare Data Act of 2007

This year, Senators Charles Grassley (R-Iowa) and Max Baucus (D-Mont) have been on more of a tear than usual regarding the FDA.  A lot of their focus this year has been on post-marketing surveillance of drugs and devices.  They are … Continue reading

Posted in Drug Safety, Proposed Legislation | 2 Comments

FDA and Pharma Images – A Conversation with Patrick Clinton – Pharmaceutical Executive Magazine

As noted in this space many times, the images of the Food and Drug Administration as well as the pharmaceutical industry have been suffering greatly, most certainly in the post-COX-2 era.  The result has been a rash of lawsuits, congressional … Continue reading

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Weekly Roundup – 5-25-07

It is hard to believe that it is already Memorial Day Weekend.  The year is slipping by so fast.  Now we sit on the cusp of summer – the honeysuckle is blooming in my yard and the scent will wash … Continue reading

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Compare and Contrast – EMEA and FDA on Avandia

The FDA issued a press release on the issuance of a safety alert on Avandia  on May 21.  On May 23, the European Medicines Agency (EMEA) also released a statement on Avandia safety.  I thought it interesting to compare the … Continue reading

Posted in Drug Safety, FDA Image | 2 Comments