Category Archives: Warning Letters

Weekly Roundup – 4-5-13

The daffodils are up and being rounded up in bunches and slipped into vases around the house, spreading good cheer, but overall Spring is still seemingly quite shy though indications are that is about to change.  It is perhaps a … Continue reading

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Some Digital and Social Media Guidance – FDA Regulation of Pharma Communications in a Digital Era – A White Paper

I have been working to assemble  a data base of  FDA/OPDP Warning and NOV letters spanning the years 2004-present, tracking activity through a number of fields.  The database now includes hundreds of letters and covers nearly 1000 violations cited by … Continue reading

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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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