What does it actually take to get a psychedelic drug approved by the FDA? In this interview, A Drug Development Expert Explains the FDA's Psychedelic Trials. With over 35 years of experience, Dr. Linda Strause breaks down the entire "long and arduous" process. Learn about the pre-clinical requirements, the different phases of human testing, and what the FDA looks for before approving a new medicine. This is a rare, insider's look at the future of psychedelic trials. Check out the company: https://psly.com
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🕒 CHAPTERS
00:00 - An Insider's Look at Psychedelic Drug Development
03:37 - A Personal Tragedy That Changed My Career
07:02 - Why Psychedelics Are Following the FDA Pathway
10:28 - The FDA Approval Process Explained by an Expert
13:37 - How to Read a Drug's "Package Insert"
17:00 - Pre-Clinical: The First Step in Any Drug Trial
20:26 - How Psychedelics "Rewire" Your Brain's Neural Connections
23:43 - Psychedelics vs. SSRIs: A Side Effect Comparison
26:48 - The Problem with Being on Multiple Medications
30:09 - Why We Have Cannabinoid Receptors in Our Brains
33:27 - The Future of Psychedelic-Assisted Therapy
36:35 - "Adult Use" vs. "Recreational": A Key Distinction
39:36 - Will Psychedelics Ever Be Approved Without Therapy?
43:02 - The Most Important Thing to Understand in Any Industry
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â–¶ Sponsor the Channel: https://www.welivetobuild.com/collaborate
â–¶ My AI/Automation Agency: https://optimai.ai
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