Texas § 491.056 INVESTIGATIONAL NEW DRUG APPLICATION.

Texas Statutes

§ 491.056 — INVESTIGATIONAL NEW DRUG APPLICATION.

Texas § 491.056

Code HSHealth and Safety Code

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Bluebook

Tex. Health and Safety Code Code Ann. § 491.056 (2026).

Text

Sec. 491.056. INVESTIGATIONAL NEW DRUG APPLICATION. On the commission's notification that a consortium is selected to conduct the drug development clinical trials under this subchapter, a drug developer or hospital member of the selected consortium or the lead institution of higher education of the consortium, as specified by written agreement of the consortium members, shall, as soon as practicable:

(1)submit an investigational new drug (IND) application to the United States Food and Drug Administration in accordance with 21 C.F.R. Part 312; and

(2)seek a breakthrough therapy designation for ibogaine from the United States Food and Drug Administration under 21 U.S.C. Section 356.

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Sec. 491.056. INVESTIGATIONAL NEW DRUG APPLICATION. On the commission's notification that a consortium is selected to conduct the drug development clinical trials under this subchapter, a drug developer or hospital member of the selected consortium or the lead institution of higher education of the consortium, as specified by written agreement of the consortium members, shall, as soon as practicable:
(1) submit an investigational new drug (IND) application to the United States Food and Drug Administration in accordance with 21 C.F.R. Part 312; and
(2) seek a breakthrough therapy designation for ibogaine from the United States Food and Drug Administration under 21 U.S.C. Section 356.