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30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 19 Product Lifecycle Management and Post-Approval Changes
This episode explores pharmaceutical product lifecycle management, focusing on what happens after FDA drug approval. It explains how companies can make post-approval changes through different regulatory pathways (CBE0, CBE30, and PAS). The discussion covers Quality by Design (QbD) principles, mutagenic impurities, and the unique challenges of botanical drug development. The episode emphasizes the importance of regulatory frameworks in maintaining drug safety and efficacy while allowing for necessary manufacturing improvements and innovations.
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By Jim Mitchell and Google NotebookLMThis episode explores pharmaceutical product lifecycle management, focusing on what happens after FDA drug approval. It explains how companies can make post-approval changes through different regulatory pathways (CBE0, CBE30, and PAS). The discussion covers Quality by Design (QbD) principles, mutagenic impurities, and the unique challenges of botanical drug development. The episode emphasizes the importance of regulatory frameworks in maintaining drug safety and efficacy while allowing for necessary manufacturing improvements and innovations.