HB4242: To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to issue guidance on considerations for conducting clinical trials for psychedelic assisted therapy.
- 1Introduced (current step)
- 2Passed One Chamber
- 3Passed Both Chambers
- 4Became Law
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Bill information
Summary
To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to issue guidance on considerations for conducting clinical trials for psychedelic assisted therapy.
Plain-language summary
This bill directs the Food and Drug Administration to create official guidance on how to conduct clinical trials for psychedelic-assisted therapy, which uses drugs like psilocybin or MDMA alongside mental health treatment. Clinical trials are studies testing whether new medicines are safe and effective in humans. The guidance would help researchers and companies understand FDA requirements and expectations for this emerging treatment area. The bill is currently introduced, meaning it has been formally submitted but not yet assigned to a for review.
AI-generated summary
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HB4242: To direct the Secretary of Health and Human Services, acting through the Commis…