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Trust the reProcess? A Practical and Legal Overview of Reprocessing Single-Use Medical Devices in the United States | Butler Snow LLP

Allow me to set the stage. Our plaintiff claims he felt a nagging pain in his shoulder for months and finally went to see the local orthopedic surgeon. The surgeon apparently informed. ....

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FDA's Final Clinical Decision Support Guidance: The Good News and the (Really) Bad News | King & Spalding

On September 28, 2022, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited final guidance, “Clinical Decision Support Software” (the “Final CDS. ....

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FDA Cigarette Graphic Warning Rule Delayed … Again | Troutman Pepper

In a prior update, we discussed the ongoing legal challenges to the U.S. Food and Drug Administration’s (FDA) March 2020 rule on a graphic-warning requirement for cigarettes. Initially. ....

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A New Day (And A New Acronym) For OTC Drugs | King & Spalding

A New Day (And A New Acronym) For OTC Drugs | King & Spalding
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Court Counters FDA Hasty Authority on Cigars Labeled Under TCA

The Court has addressed the central issue of whether FDA should have ever deemed premium cigars to be subject to the Tobacco Control Act in the first place – ruling that doing so was arbitrary and capricious in violation of the Administrative Procedure Act APA. ....

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