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This introductory episode of a 30-day podcast series explores FDA drug development through the lens of cannabis and psychedelic therapeutics. The conversation covers fundamental concepts including cGMP (current good manufacturing practices), ICH guidelines, quality by design, and label accuracy. The hosts emphasize how these regulations ensure drug safety and efficacy while addressing the unique challenges of developing cannabis and psychedelic medicines. The discussion delves into the FDA's role in protecting public health, the importance of standardization, and the broader societal impact of bringing these controversial substances into mainstream medicine.
By Jim Mitchell and Google NotebookLMThis introductory episode of a 30-day podcast series explores FDA drug development through the lens of cannabis and psychedelic therapeutics. The conversation covers fundamental concepts including cGMP (current good manufacturing practices), ICH guidelines, quality by design, and label accuracy. The hosts emphasize how these regulations ensure drug safety and efficacy while addressing the unique challenges of developing cannabis and psychedelic medicines. The discussion delves into the FDA's role in protecting public health, the importance of standardization, and the broader societal impact of bringing these controversial substances into mainstream medicine.