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.
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.
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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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.