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Guidelines for Clinical Trials of Psychedelic-Assisted Therapy

This bill directs the Food and Drug Administration (FDA) to issue clear guidelines for conducting clinical trials on psychedelic-assisted therapies. This aims to facilitate and accelerate research into potential new treatments, which could eventually lead to new therapeutic options for citizens.
Key points
The FDA must issue draft guidelines within 180 days of the bill's enactment.
The guidelines will assist in conducting research on psychedelic therapies, including how to seek FDA support.
Final guidelines will be published within 180 days of the draft, following public comment.
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Additional Information
Print number: 118_HR_4242
Sponsor: Rep. Crenshaw, Dan [R-TX-2]
Process start date: 2023-06-21
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OFFICIAL LEGAL TITLE

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.

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 118_HR_4242.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

When did the legislative process begin?

The process officially started on 2023-06-21.

What are the main provisions?

Key points include:

  • The FDA must issue draft guidelines within 180 days of the bill's enactment.
  • The guidelines will assist in conducting research on psychedelic therapies, including how to seek FDA support.
  • Final guidelines will be published within 180 days of the draft, following public comment.
What is the specific legal status?

The current status is Expired.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Rep. Crenshaw, Dan [R-TX-2].

What is the latest detailed status?

The latest detailed status is: Referred to the Subcommittee on Health.

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-25.

CATEGORIES

Health