Sec. 1124. ADVANCING REGULATORY SCIENCE TO PROMOTE PUBLIC HEALTH INNOVATION
688 words·~3 min read·
/statute-compilations/comps-9932/sec-1124A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
## SEC. 1124 ADVANCING REGULATORY SCIENCE TO PROMOTE PUBLIC HEALTH INNOVATION **[**[21 U.S.C. 393 note](/us/usc/t21/s393)**]** ###
(a)In General Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall develop a strategy and implementation plan for advancing regulatory science for medical products in order to promote the public health and advance innovation in regulatory decisionmaking. ###
(b)Requirements The strategy and implementation plan developed under subsection
(a)shall be consistent with the user fee performance goals in the Prescription Drug User Fee Agreement commitment letter, the Generic Drug User Fee Agreement commitment letter, and the Biosimilar User Fee Agreement commitment letter transmitted by the Secretary to Congress on January 13, 2012, and the Medical Device User Fee Agreement commitment letter transmitted by the Secretary to Congress on April 20, 2012, and shall— ####
(1)identify a clear vision of the fundamental role of efficient, consistent, and predictable, science-based decisions throughout regulatory decisionmaking of the Food and Drug Administration with respect to medical products; ####
(2)identify the regulatory science priorities of the Food and Drug Administration directly related to fulfilling the mission of the agency with respect to decisionmaking concerning medical products and allocation of resources toward such regulatory science priorities; ####
(3)identify regulatory and scientific gaps that impede the timely development and review of, and regulatory certainty with respect to, the approval, licensure, or clearance of medical products, including with respect to companion products and new technologies, and facilitating the timely introduction and adoption of new technologies and methodologies in a safe and effective manner; ####
(4)identify clear, measurable metrics by which progress on the priorities identified under paragraph
(2)and gaps identified under paragraph
(3)will be measured by the Food and Drug Administration, including metrics specific to the integration and adoption of advances in regulatory science described in paragraph
(5)and improving medical product decisionmaking, in a predictable and science-based manner; and ####
(5)set forth how the Food and Drug Administration will ensure that advances in regulatory science for medical products are adopted, as appropriate, on an ongoing basis and in an manner integrated across centers, divisions, and branches of the Food and Drug Administration, including by senior managers and reviewers, including through the— #####
(A)development, updating, and consistent application of guidance documents that support medical product decisionmaking; and #####
(B)adoption of the tools, methods, and processes under section 566 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-5). ###
(c)Performance Reports The annual performance reports submitted to Congress under sections 736B(a) (as amended by section 104 of this Act), 738A(a) (as amended by section 204 of this Act), 744C(a) (as added by section 303 of this Act), and 744I(a) (as added by section 403 of this Act) of the Federal Food, Drug, and Cosmetic Act for each of fiscal years 2014 and 2016, shall include a report from the Secretary on the progress made with respect to— ####
(1)advancing the regulatory science priorities identified under paragraph
(2)of subsection
(b)and resolving the gaps identified under paragraph
(3)of such subsection, including reporting on specific metrics identified under paragraph
(4)of such subsection; ####
(2)the integration and adoption of advances in regulatory science as set forth in paragraph
(5)of such subsection; and ####
(3)the progress made in advancing the regulatory science goals outlined in the Prescription Drug User Fee Agreement commitment letter, the Generic Drug User Fee Agreement commitment letter, and the Biosimilar User Fee Agreement commitment letter transmitted by the Secretary to Congress on January 13, 2012, and the Medical Device User Fee Agreement transmitted by the Secretary to Congress on April 20, 2012. ###
(d)Medical Product In this section, the term “medical product” means a drug, as defined in subsection
(g)of section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), a device, as defined in subsection
(h)of such section, or a biological product, as defined in section 351(i) of the Public Health Service Act.
Connectionstraces to 3
Traces to 3 documents
Citation graph
cites case law
Sec. 1124
ADVANCING REGULATORY SCIENCE TO PROMOTE PUBLIC HEALTH INNOVATION
Cites 3Cited by 0 across 0 sources