Monthly Archives: May 2007

Risk Management Workshop

The FDA is scheduled to announce today a Risk Management Workshop designed to discuss such programs and share information among key stekholders.  Risk Management has been an increasing source of concentration in the post-COX-2 era.  There were compounds prior to … Continue reading

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Congressional Hearing on FDA’s Handling of Avandia

I don’t know what the record is for announcing a Congressional investigation after breaking news, but the title may go to Congressman Henry Waxman (D-CA), under whose feet no grass grows.  I think he may hold the record.  There has … Continue reading

Posted in Drug Safety, FDA Image, Industry Image | 1 Comment

Supplements and Adverse Event Reporting – A Conversation with the Council for Responsible Nutrition

As reported in the past here, the 109th Congress passed S.3546 – The Dietary and Supplement Non-Prescription Drug Consumer Act – legislation that would make it mandatory for manufacturers of dietary supplements and OTC products to report serious adverse events.  … Continue reading

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Weekend Approvable Letters

Sometimes the FDA sends action letters to companies late on Friday.  When it is an approval letter, that can be unfortunate, as companies have the unenviable task of either holding the news until Monday or announcing it to a lackluster … Continue reading

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Weekly Roundup – 5-18-07

The weather has been beautiful here inside the Beltway.  We are already on the cusp of summer and in a few weeks, we will have Memorial Day and we can break out our summer whites!  USDA Clears Swine for Food … Continue reading

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