Category Archives: Warning Letters

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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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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