A Drug Development Expert Explains the FDA's Psychedelic Trials

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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