Category Archives: Warning Letters

Warning and NOV Letter Summary – 2nd Quarter 2012

In addition to it being a very hot summer, it has been an extraordinarily busy one and I am a bit tardy in bringing the quarterly summary of Warning and NOV letters put out by the Office of Prescription Drug … Continue reading

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Warning and NOV Letter Summary – 1st Quarter 2012

Another quarter has zoomed by.  And with it, FDA’s Office of Prescription Drug Promotion (OPDP), formerly known as the Division of Drug Marketing, Advertising and Communications (DDMAC), has issued a stream of regulatory action letters known as Notice of Violation … Continue reading

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Weekly Roundup 5-4-12

Wondering by the end of the day how many people will post “May the 4th be with you” on Facebook.  So far I am in double digits…. We are in May.  Hard to believe.  I am thinking that there are … Continue reading

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FDA Sends Out 10 Warning Letters to Dietary Supplement Manufacturers

10 Count ‘em 10. That is how many Warning Letters the agency sent out last Friday to manufacturers and distributors of dietary supplements.  The specific focus of the letters was products that were being marketed containing dimethylamylamine, also known as … Continue reading

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Warning and NOV Letter Summary – 4th Quarter 2011

Each quarter Eye on FDA provides a brief recap of the regulatory action letters issued respecting the promotion of prescription drugs. The office that issues the letter underwent a change during 2011, changing its name in the process from the … Continue reading

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