Category Archives: Warning Letters

OPDP Issues Untitled Letter Involving Social Media

Sort of. There is, of course, a difference between a regulatory action letter that is issued because of a social media use and a regulatory action letter that is issued the communication happens to involve a social media platform.  In … Continue reading

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Warning and NOV Letter Summary – 4th Quarter 2013

I usually wait a little bit longer after the end of the quarter to write up a summary of letters issued by the Office of Prescription Drug Promotion (OPDP) because there can sometimes be a healthy lag time between the … Continue reading

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Risky Business – Risk Information and Promotion

In my data base of Office of Prescription Drug Promotion (OPDP) Warning and Untitled Letters issued during the years 2004-2013, one of the many fields I track is, of course, the type of violations that were incurred. There are many, … Continue reading

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Warning and Untitled Letters and Spoken Words

Pulling on my database on Warning and Untitled Letters over the past ten years, I had occasion to look up those violations over the past 10 years that involved the spoken word. The database profiles each letter and tracks various … Continue reading

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Warning Letters and Boxed Warnings

My data base on warning and untitled letters now includes the years 2004-today.  It includes 282 letters covering a neat total of 1000 different violations.  When I was working on it earlier, I did a post looking at letters aimed … Continue reading

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