30 Day FDA Drug Development in Ca...
30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 25 Global Perspectives and Harmonization

Cannabinoid and Psychedelic Pharmacology and Drug Developmen... by Jim Mitchell and Google NotebookLM

Episode notes

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.