Monthly Archives: January 2007

The New FDA Drug Safety Initiative – Policy and Communications Implications

Yesterday the FDA announced yet another new initiative on drug safety.  This is apparently in addition to the pre-existing Drug Safety Initiative.  It is an action taken in response to the Institute of Medicine (IOM) report – The Future of … Continue reading

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The EMEA and the FDA

Last week, a report was issued by the Tufts Center for Drug Development that showed that while the European Medicines Agency (EMEA) – the European Union’s FDA equivalent – had met its performance goals, it was nevertheless lagging behind the … Continue reading

Posted in Miscellaney | 3 Comments

Weekly Roundup 1/26/07

Already the first month of the new year draws to a close.  We’ve heard about the State of the Union, such that it is.  The days, thankfully, grow longer.  And at the FDA, there have been another huge batch of … Continue reading

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Approvable Letter Issued to Wyeth

Following a rash of approvable letters at the end of 2006 for a number of products, Wyeth Pharmaceuticals announced that it has received an FDA approvable letter on January 22 for Pristiq (TM) – desvenlafaxine succinate – a serotonin-norepinephrine reuptake … Continue reading

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Warning Letter Summary for 4th Quarter 2006

A total of seven companies received Warning Letters during the last quarter, meaning that one-third of the year’s letters came in the final three months of the year.  What we saw is a mix of large and small companies, with … Continue reading

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