Sec. 2041. Precision medicine guidance and other programs of Food and Drug Administration
543 words·~2 min read·
/bill/114/hr/6/ih/section-2041A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq. ) is amended by adding at the end the following: The Secretary shall issue and periodically update guidance to assist sponsors in the development of a precision drug or biological product. Such guidance shall— define the term precision drug or biological product ; and address the topics described in subsection (b). The topics to be addressed by guidance under subsection
(a)are— the evidence needed to support the use of biomarkers (as defined in section 507(e)) that identify subsets of patients as likely responders to therapies in order to streamline the conduct of clinical trials; recommendations for the design of studies to demonstrate the validity of a biomarker as a predictor of drug or biological product response; the manner and extent to which a benefit-risk assessment may be affected when clinical trials are limited to patient population subsets that are identified using biomarkers; the development of companion diagnostics in the context of a drug development program; and considerations for developing biomarkers that inform prescribing decisions for a drug or biological product, and when information regarding a biomarker may be included in the approved prescription labeling for a precision drug or biological product. The Secretary shall issue guidance under subsection
(a)not later than 18 months after the date of the enactment of the 21st Century Cures Act. In the case of a precision drug or biological product that is the subject of an application submitted under section 505(b)(1), or section 351(a) of the Public Health Service Act, for the treatment of a serious or life-threatening disease or condition and has been designated under section 526 as a drug for a rare disease or condition, the Secretary may— consistent with applicable standards for approval, rely upon data or information previously submitted by the sponsor of the precision drug or biological product, or another sponsor, provided that the sponsor of the precision drug or biological product has obtained a contractual right of reference to such other sponsor’s data and information, in an application approved under section 505(c) or licensed under section 351(a) of the Public Health Service Act, as applicable— for a different drug or biological product; or for a different indication for such precision drug or biological product, in order to expedite clinical development for a precision drug or biological product that is using the same or similar approach as that used to support approval of the prior approved application or license, as appropriate; and as appropriate, consider the application for approval of such precision drug or biological product to be eligible for expedited review and approval programs described in section 506, including accelerated approval in accordance with subsection
(c)of such section. Nothing in this section shall be construed to— limit the authority of the Secretary to approve products pursuant to this Act and the Public Health Service Act as authorized prior to the date of enactment of this section; or confer any new rights, beyond those authorized under this Act prior to enactment of this section, with respect to a sponsor’s ability to reference information contained in another application submitted under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act. .
Connectionstraces to 1
Traces to 1 document
U.S. Code
Citation graph
cites case law
Sec. 2041
Precision medicine guidance and other programs of Food and Drug Administration
Cites 1Cited by 0 across 0 sources