Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
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Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
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About this listen
In this episode of Holland & Knight's "The Eyes on Washington" podcast series, attorneys Rachel Gartner, Sara Klock, John Vaughan and Michael Werner discuss the evolving landscape of U.S. Food and Drug Administration (FDA) regulation throughout the early months of the Trump Administration. Key topics include the significant organizational changes at the FDA, ongoing legal battles over compounded GLP-1 drugs and their market access, regulatory uncertainties surrounding laboratory-developed tests (LDTs) and anticipated reforms in food ingredient safety and cosmetic product oversight. The conversation also explores the administration's shifting approach to the regulation of artificial intelligence (AI) in healthcare, predicting a lighter federal touch with increased state-level involvement and industry self-regulation. Additionally, the episode touches on the status of cannabis regulation and the fluid nature of enforcement and policy amid changes in the federal government, offering listeners valuable insights into navigating the current FDA regulatory environment.