Category Archives: Warning Letters

Look Back at OPDP Enforcement in 2016 – Focus on Pre Approval Communications

It was another year of low-level enforcement by the FDA Office of Prescription Drug Promotion (OPDP). In fact, if you added the number of letters issued over the past three years it would be one less than the number of … Continue reading

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Additional Untitled Letters Issued by OPDP

It has been a rather extraordinary month for watchers of the Office of Prescription Drug Promotion (OPDP) in that while the office has issued very little enforcement during the bulk of the year, December has been making up for it. … Continue reading

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OPDP Makes a Point on Risk Info and DTC (Updated)

The Office of Prescription Drug Promotion (OPDP) has been particularly low-key this year when it comes to visible enforcement actions expressed through the issuance of Warning or Untitled letters. Up until this week, the office had issued only 5 letters … Continue reading

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Weekly Roundup 11.4.16

We are almost through it! ┬áJust a few more days. In the meantime, the more enjoyable aspects of autumn, chilly nights, fires in the fireplace, and brilliant leaves are all upon us. Soon the end of year holidays will be … Continue reading

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The Drop in OPDP Enforcement

Back when the Office of Prescription Drug Promotion (OPDP) issued regulatory action letters on a regular basis (either Warning Letters or Untitled Letters) regarding what the agency saw as infractions in the course of promotional speech, I would post a … Continue reading

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