Category Archives: Warning Letters

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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How We Communicate Matters – Comparing Communications Vehicles and Regulatory Enforcement

One of the benefits of tracking the regulatory actions of FDA through the Office of Prescription Drug Promotion (OPDP) is that it allows you to take the information and view it from different perspectives to look for interesting lessons and … Continue reading

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Review of Warning and Untitled Letters for 2014

Earlier this month, I had posted about the steep decline in FDA’s OPDP enforcement rates as the number of Warning and Untitled letters for 2014 hit a new low of only ten for the year. In the posting, I had … Continue reading

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Warning and NOV Letters Plummet in 2014

There are two types of letters issued by FDA’s Office of Prescription Drug Promotion (OPDP) related to its role in regulating the commercial speech of medical product manufacturers – Warning Letters (WLs) and Notice of Violation (NOV) letters. One can … Continue reading

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DTC and Regulatory Enforcement

FDA’s OPDP views nearly all industry communication – whatever the venue and intent – through a lens of advertising. ¬†Certainly a big focus of regulatory enforcement has been direct-to-consumer advertising and for a long time, there has been guidance available … Continue reading

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