Sec. 2. Clinical trial modernization
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Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 506F ( 21 U.S.C. 356f ) the following new section: To promote the efficiency of the development and regulatory review and approval, licensure, or clearance of drugs, biological products, and devices and the timely availability of innovative treatments, the Secretary shall, after providing notice and an opportunity for public comment, establish and implement a framework through which— sponsors of drugs, biological products, or devices may submit to the Secretary a proposal for the incorporation of adaptive trial designs, Bayesian methods, or other alternative statistical methods into proposed clinical protocols and marketing applications for drugs, biological products, or devices; and the Secretary will commit to timelines for reviewing and providing feedback on proposals so submitted. .
The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs (in this subsection referred to as the Secretary ), shall— update and finalize the draft guidance addressing the use of adaptive trial design for drugs and biological products; and issue draft guidance on the use of Bayesian methods in the development and regulatory review and approval, licensure, or clearance of drugs, biological products, and devices. The guidances under paragraph
(1)shall— establish or clarify standards for using adaptive trial designs and Bayesian methods in clinical trials, including clinical trials that form the primary basis for approval, clearance, or licensure of the products involved (such as trials that provide substantial evidence for the approval of drugs); establish a mechanism for sponsors to obtain feedback from the Secretary under section 507, as added by subsection (a), on technical issues related to modeling and simulations prior to— completion of such modeling or simulations; or the submission of resulting information to the Secretary; specify the types of quantitative and qualitative information required for review; and specify the recommended analysis methodology. Prior to updating or developing the guidances required by paragraph (1), the Secretary shall consult, through a public meeting to be held no later than 1 year after the date of enactment of this Act, with stakeholders including representatives of regulated industry, academia, patient advocacy organizations, and disease research foundations. The Secretary shall, after providing notice and opportunity for public comment, publish— the final guidance required by paragraph (1)(A) not later than 6 months after the date of the public meeting required by paragraph (3); and the guidance required by paragraph (1)(B) not later than 12 months after the date of the public meeting required by paragraph (3). Not later than 48 months after the date of enactment of this Act, the Secretary shall review and, as appropriate, revise the guidance documents required by subparagraphs
(A)and
(B)of paragraph
(1)to reflect developments in statistical methods that could be appropriate for use in clinical trials, including clinical trials that— form the primary basis for approval, clearance, or licensure of drugs, biological products or devices; or provide substantial evidence for the approval of drugs.
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Sec. 2
Clinical trial modernization
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