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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.

H.R. 4242 · 118th Congress · Jun 21, 2023 · Lineage

A BILL

Section 1 Guidance on considerations for conducting clinical trials for psychedelic assisted therapy

The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall—
(1)
not later than 180 days after the date of enactment of this Act, issue for public comment draft guidance on considerations for conducting clinical trials for psychedelic assisted therapy, including how those seeking an investigational use exemption for such clinical trials should request interactive support by the Food and Drug Administration; and
(2)
not later than 180 days after issuing such draft guidance, finalize such guidance.