Category Archives: Warning Letters

Fewer Letters, Fewer Warning Letters

It may seem that I write a lot about the letters that FDA puts out regarding industry promotion and communication, but that is exactly what the nature of this blog is about. Other things can be interesting, particularly policy developments, … Continue reading

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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

Posted in New and Social Media, Warning Letters | 4 Comments