Monthly Archives: August 2023

Drug Approvals and FDA AdComms in 2023

Posted on August 28, 2023 by Mark Senak

Having passed the mid-year point, it is always an interesting exercise to take stock of where we stand with respect to the approval of new medicines. Overall, when considering the volume of activity, things would seem to be looking up … Continue reading →

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FDA’s OPDP Issues Third Letter of 2023

Posted on August 22, 2023 by Mark Senak

For the second time this month and the third time this year, FDA’s OPDP has posted notice that it has taken an enforcement action. Last week, a Warning Letter was posted regarding a sales aid. This week it action came … Continue reading →

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FDA’s OPDP Issues Second Regulatory Action Letter of 2023

Posted on August 16, 2023 by Mark Senak

In what has been a long period of relative low activity, FDA’s OPDP has taken the opportunity to remind us that low enforcement does not mean no enforcement when it comes to promotional speech by pharmaceutical companies. This past June … Continue reading →

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What They Said – Reviewing the First 6-Months of FDA Communications

Posted on August 10, 2023 by Mark Senak

Every six months, we do a look-back to see what has changed in the way that FDA is communicating. One might not think there is much difference over time, but there is. For example, the air has pretty much gone … Continue reading →

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