Category Archives: Warning Letters

Warning and NOV Letter Summary – 2d Quarter 2013

It is so hard to believe the year is half gone, but it is and that means – among other things – that it is time to look at the past quarter of enforcement letters from the Office of Prescription … Continue reading

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Webinar on FDA Communications Oversight in a Digital Era

Many may recall that in early April, I released a paper I did here on Eye on FDA called “FDA Communications Oversight in a Digital Era” that examined the patterns of enforcement by FDA’s Office of Prescription Drug Promotion as … Continue reading

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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

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