FDA package inserts directly mirror clinical trial design and adverse events
Dr. Linda Strauss · Psilocybin Breaks Neural Connections - Then Therapy Rewires Them · Apr 28, 2022 · at 13:09
Dr. Linda Strauss, biochemist and clinical trial expert, explains how FDA drug labeling and package inserts are generated from trial protocols and findings.
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“If you read that package insert, You could write an entire drug development pathway for that product because who it's indicated for were all the inclusion exclusion criterias that were there. All the side effects were all the adverse events that were collected during the conduct of that study, and you can go on and on.”
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