Category Archives: Warning Letters

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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OPDP Letters for Promotion of Investigational Compounds, Part 1

As many know, I have put together a data base for my use that tracks the letters sent by FDA’s Office of Prescription Drug Promotion (OPDP) since 2004 – tracking company, date, indication, product name, type of communications vehicle and … Continue reading

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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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