Sec. 3. Improvements to program for grants for research on therapies for ALS
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/bill/119/hr/8205/ih/section-3A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 2(b) of the Accelerating Access to Critical Therapies for ALS Act ( 21 U.S.C. 360ee note) is amended by adding at the end the following: In reviewing applications for renewals of a grant awarded under this section with respect to an investigational drug, the Secretary shall assess the status of a clinical trial carried out for such drug with respect to data on enrollment of patients in such clinical trial. To enable the Secretary to make the assessment under subparagraph
(A)with respect to an investigational drug, the Secretary shall request that the manufacturer of the investigational drug share interim clinical trial data with respect to such drug with the Secretary. . Section 2(e) of the Accelerating Access to Critical Therapies for ALS Act ( 21 U.S.C. 360ee note) is amended by adding at the end the following: The term phase 3 , with respect to a clinical trial, includes a phase 2/3 combined trial and a planned phase 3 clinical trial that is not yet enrolling participants. .
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Sec. 3
Improvements to program for grants for research on therapies for ALS
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