Category Archives: Warning Letters

FDA Enforcement on Promotional Communications – 2015 Summary

Happy New Year. That means that it is that time for some of those look-back postings where we look at what FDA has and has not accomplished in the course of the year we have just been through. In many … Continue reading

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A Look Back at Regulatory Enforcement by Therapeutic Category

In past years, I have always provided quarterly updates of the Warning and Untitled Letters that the Office of Prescription Drug Promotion (formerly DDMAC) puts out, regulating the promotion of pharmaceutical products. However, with only one letter issued each month … Continue reading

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OPDP Issues Warning Letter on Social Media Posting

OMG. Can’t say that I ever thought I would be writing about Kim Kardashian here on Eye on FDA, but that just goes to show you, life always entertains surprises. This week FDA posted a Warning Letter issued to a … Continue reading

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Warning and NOV Letter Summary – 1st Quarter 2015

In the years past when the Office of Prescription Drug Promotion (OPDP) issued Warning Letters (WL) and Notice of Violation (NOV) letters with regularity, it was the custom here at Eye on FDA to review them on a quarterly basis. … Continue reading

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Is Bigger Safer? OPDP Enforcement Patterns and Company Size

Eye on FDA has frequently carried overviews and summaries of enforcement by the Office of Prescription Drug Promotion (OPDP) through the issuance of Warning and Untitled Letters (regulatory action letters). These letters, along with guidance documents that are occasionally issued … Continue reading

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