Category Archives: Regulatory Communications

FDA’s OPDP Issues Two New Untitled Letters

While enforcement has been at a low ebb for quite some time with FDA’s Office of Prescription Drug Promotion (OPDP), this week took a different turn with the posting of two new untitled letters sent October 31. That brings the … Continue reading

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Tick Tock re Tik Tok and FDA’s OPDP

Tik Tok was first released in 2016. While slow out of the starting gate with emergent media opportunities, in 2022, pharma is embracing the platform in both unbranded and branded efforts. While historically, a lot of Tik Tok use has … 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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A Serial on Cereal – The FDA and the FTC

In May of last year, the Food and Drug Administration sent a Warning Letter to General Mills about a box of Cheerios.   The problem?  The FDA read the Cheerios box and didn't like what they saw when it came … Continue reading

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A Bitter Pill to Swallow – The Perils in Off Label Promotion

On September 29, the US. Attorney's Office for the Northern District of California announced that a former CEO of InterMune was convicted of wire fraud for the "creation and dissemination of false and misleading information about the efficacy of InterMune's … Continue reading

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