Category Archives: Warning Letters

Warning and NOV Summary – 1st Quarter 2013

Each quarter I regularly try to provide a little insight into OPDP’s current thinking as expressed through the issuance of Warning and NOV letters.  What we saw last year is that the number of such letters after rising a bit … Continue reading

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Comparing Types of Violations Between Digital and Non-Digital

In the wake of publishing “FDA Communications Oversight in a Digital Era” in last week’s blog post, I have been asked some interesting questions.  One of them sought to know whether there was a difference between the types of violations … Continue reading

Posted in Social Media, Warning Letters | 1 Comment

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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