Category Archives: Warning Letters

Warning and NOV Summary – 4th Quarter 2012

To gain insight into the most recent thinking at FDA’s Office of Prescription Drug Promotion (OPDP), Eye on FDA regularly reviews the number of letters and types of violations that were cited by the agency each quarter in Warning Letters … Continue reading

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Viewing Video’s Regulatory Profile

Happy Election Day.  Make sure you vote! Are you considering putting together a video that contains a patient of physician testimonial?  If you are, you will want to take extra care in considering two things – how you present your … Continue reading

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Warning and NOV Letter Summary – 3rd Quarter 2012

Each quarter Eye on FDA examines what has occurred in enforcement by the Office of Prescription Drug Promotion (OPDP), formerly known as the Division of Drug Marketing, Advertising, and Communications (DDMAC).  Apart from being instructive for those working in communications … Continue reading

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Boxed Warnings and Warning Letters

Last week I reported on some of the activities during the Food and Drug Law Institute meeting on Advertising and Promotion which I attended here in Washington, where many aspects of enforcement were discussed.  I had some data I did … Continue reading

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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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