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30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 14 Botanical Drug Development Guidance (FDA)
This episode explores the complexities of botanical drug development, focusing on cannabis and psychedelic mushrooms. The discussion covers key quality control challenges, including the variability of active compounds in natural products and the importance of standardization. The episode explains crucial regulatory frameworks like the Botanical Drug Master File (BDMF) and ICHM7 guidelines, which ensure product safety and consistency. It also delves into extraction methods, purification processes, and the importance of accurate labeling for consumer safety. The conversation emphasizes the role of third-party testing and quality certifications in maintaining product integrity and building consumer trust.
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By Jim Mitchell and Google NotebookLMThis episode explores the complexities of botanical drug development, focusing on cannabis and psychedelic mushrooms. The discussion covers key quality control challenges, including the variability of active compounds in natural products and the importance of standardization. The episode explains crucial regulatory frameworks like the Botanical Drug Master File (BDMF) and ICHM7 guidelines, which ensure product safety and consistency. It also delves into extraction methods, purification processes, and the importance of accurate labeling for consumer safety. The conversation emphasizes the role of third-party testing and quality certifications in maintaining product integrity and building consumer trust.