Category Archives: Warning Letters

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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Warning and NOV Letter Summary – 3rd Quarter 2013

Government shut down or no government shut down, the read for Warning and NOV letters out of the Office of Prescription Drug Promotion (OPDP) is slim pickings. It is always a good idea at the end of the quarter to … Continue reading

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OPDP Letters for Promotion of Investigational Compounds, Part 2

In my last posting, I provided an overview from my database of Warning and Untitled (NOV) letters data base that spans the years 2004 – present regarding FDA actions around communications perceived by the agency to be promoting an investigational … Continue reading

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