Category Archives: Warning Letters

OPDP Issues First Regulatory Action Letter of 2022

FDA’s Office of Prescription Drug Promotion (OPDP) issued the first regulatory action letter for 2022. This one has some notable characteristics. As has been frequently noted, enforcement actions by OPDP have diminished considerably over the years. Another characteristic of recent … Continue reading

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OPDP Sends Untitled Letter

Upfront Author’s Note: This is the first posting in a while as I have been working to migrate the subscription service to a new provider. As such, some subscribers were lost in the process. Anyone who signed up for a … Continue reading

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OPDP Warning and Untitled Letters – A Separation; a New Letter from OPDP

This is sort of a two-for posting. First we will look at a change in how FDA is reporting regulatory actions by OPDP on the FDA website, and second we will cover the most recent such action. OPDP Warning Letter … Continue reading

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2020 OPDP Enforcement

Last month we looked at a review of FDA press releases for last year and as one might have expected, there was an enormous spike in communications as a result of the COVID-19 pandemic. Looking now to a review of … Continue reading

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Time for FDA’s OPDP to Fill the Gaps on Digital and Social Media

At mid-year, it has been a custom here at Eye on FDA to look back at a few categories of activity by FDA at the first half of the year and discern what it tells us about future directions. This … Continue reading

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