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30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 23 Pharmacovigilance and Post-Marketing Surveillance
This podcast episode explores pharmacovigilance and post-market surveillance in cannabinoid and psychedelic therapies. The discussion covers how the FDA monitors drug safety after approval, the importance of real-world data collection, and the role of Risk Evaluation and Mitigation Strategies (REMS) in ensuring patient safety. The speakers examine unique challenges in monitoring these therapies, including drug interactions, subjective effects, and the importance of set and setting. They also discuss how technology and collaborative efforts between healthcare providers, researchers, and patients contribute to building a comprehensive safety framework for these emerging treatments.
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By Jim Mitchell and Google NotebookLMThis podcast episode explores pharmacovigilance and post-market surveillance in cannabinoid and psychedelic therapies. The discussion covers how the FDA monitors drug safety after approval, the importance of real-world data collection, and the role of Risk Evaluation and Mitigation Strategies (REMS) in ensuring patient safety. The speakers examine unique challenges in monitoring these therapies, including drug interactions, subjective effects, and the importance of set and setting. They also discuss how technology and collaborative efforts between healthcare providers, researchers, and patients contribute to building a comprehensive safety framework for these emerging treatments.