Monthly Archives: May 2009

Weekly Roundup – 5/29/09

Oh gosh.  The pollen count is off the charts.  Summer storms are overanxious and overabundant. The first tropical depression has appeared off the Atlantic just prior to the official beginning of the Hurricane Season.  A diabetic is ascending to the … Continue reading

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FDA’s Non-Guidance on Relating Risk Information is FDA’s Loss – Industry’s Opportunity

This week, the FDA issued a Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion.  It is more accurately referred to as a Non-Guidance.  According to FDA's DDMAC, the Internet has not really taken hold yet. … Continue reading

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Warning Letter Quarterly Update, Last Quarter 2008, First Quarter 2009, Part 2

Ok, last week, I ran a posting that profiled the rate of Warning and Untitled Letter rate from FDA's DDMAC, this week, let's look at the substance and see what, if any, lessons there are to be learned from DDMAC … Continue reading

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New Pharma in New Media – GSK Launches New Blog – Teva a New YouTube Channel

Slowly, but surely, the migration of pharmaceutical companies into new media is occurring.  Given it has b een a glacial pace, and far behind other industries.  FDA's DDMAC says one thing and does another when it comes to regulating the … Continue reading

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Margaret Hamburg Gets Unanimous Senate Approval

It could be the end of an era.   For many years, the FDA has lacked decisive leadership and strategic vision.   The agency, which was once the gold-standard of regulatory agencies, has seen that gold tarnish overtime while it … Continue reading

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