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This podcast episode explores global regulations for cannabis and psychedelic therapies, comparing approaches between the US FDA, Canada, and the EU. The discussion covers ICH guidelines for harmonizing drug development standards internationally, the role of botanical drug classifications, and the challenges of balancing innovation with accessibility. Key topics include mutagenic impurity guidelines, analytical procedures for quality control, and the integration of real-world data with clinical trial results.
By Jim Mitchell and Google NotebookLMThis podcast episode explores global regulations for cannabis and psychedelic therapies, comparing approaches between the US FDA, Canada, and the EU. The discussion covers ICH guidelines for harmonizing drug development standards internationally, the role of botanical drug classifications, and the challenges of balancing innovation with accessibility. Key topics include mutagenic impurity guidelines, analytical procedures for quality control, and the integration of real-world data with clinical trial results.