Sec. 505. Facilitating the use of real world evidence
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Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue or revise existing guidance on considerations for the use of real world data and real world evidence to support regulatory decision-making, as follows: With respect to drugs, such guidance shall address the use of such data and evidence to support the approval of a drug application under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or a biological product application under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), or to support an investigational use exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act or section 351(a)(3) of the Public Health Service Act.
Such guidance shall include considerations for the inclusion, in such applications, of real world data and real world evidence obtained as a result of the use of drugs authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ), and considerations for standards and methodologies for collection and analysis of real world evidence included in such applications, submissions, or requests, as appropriate. With respect to devices, such guidance shall address the use of such data and evidence to support the approval, clearance, or classification of a device pursuant to an application or submission submitted under section 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(k) , 360c(f)(2), 360e), or to support an investigational use exemption under section 520(g) of such Act ( 21 U.S.C. 360j(g) ).
Such guidance shall include considerations for the inclusion, in such applications, submissions, or requests, of real world data and real world evidence obtained as a result of the use of devices authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ), and considerations for standards and methodologies for collection and analysis of real world evidence included in such applications, submissions, or requests, as appropriate.
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- 21 USC 360bbb–3
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Sec. 505
Facilitating the use of real world evidence
Cite21 USC 360bbb–3
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