Category Archives: Warning Letters

Socializing Medicine – FDA Enforcement Involving Social Media

Have you ever had a conversation with someone who said pharma needs to stay away from social media because it is too risky? Even today, some hold that opinion. When social media, used primarily by individuals in its nascent stage, … Continue reading

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Promotion of Investigational Compound – Historical Overview

Communications regarding medicines in development – often referred to as “investigational compounds” can be particularly challenging. On the one hand, there are data milestones and advancements for the product through the regulatory cycle about which there is great interest. On … Continue reading

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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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