Sec. 3033. ACCELERATED APPROVAL FOR REGENERATIVE ADVANCED THERAPIES
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## SEC. 3033 ACCELERATED APPROVAL FOR REGENERATIVE ADVANCED THERAPIES ###
(a)In general Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) is amended— ####
(1)by transferring subsection
(e)(relating to construction) so that it appears before subsection
(f)(relating to awareness efforts); and ####
(2)by adding at the end the following: > > ### “(g) Regenerative Advanced Therapy > > > #### “(1) In general > > The Secretary, at the request of the sponsor of a drug, shall facilitate an efficient development program for, and expedite review of, such drug if the drug qualifies as a regenerative advanced therapy under the criteria described in paragraph (2). > > > #### “(2) Criteria > > A drug is eligible for designation as a regenerative advanced therapy under this subsection if— > > > ##### “(A) > > the drug is a regenerative medicine therapy (as defined in paragraph (8)); > > > ##### “(B) > > the drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and > > > ##### “(C) > > preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such a disease or condition. > > > #### “(3) Request for Designation > > The sponsor of a drug may request the Secretary to designate the drug as a regenerative advanced therapy concurrently with, or at any time after, submission of an application for the investigation of the drug under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act. > > > #### “(4) Designation > > Not later than 60 calendar days after the receipt of a request under paragraph (3), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (2). If the Secretary determines that the drug meets the criteria, the Secretary shall designate the drug as a regenerative advanced therapy and shall take such actions as are appropriate under paragraph (1). If the Secretary determines that a drug does not meet the criteria for such designation, the Secretary shall include with the determination a written description of the rationale for such determination. > > > #### “(5) Actions > > The sponsor of a regenerative advanced therapy shall be eligible for the actions to expedite development and review of such therapy under subsection (a)(3)(B), including early interactions to discuss any potential surrogate or intermediate endpoint to be used to support the accelerated approval of an application for the product under subsection (c). > > > #### “(6) Access to expedited approval pathways > > An application for a regenerative advanced therapy under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act may be— > > > ##### “(A) > > eligible for priority review, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012; and > > > ##### “(B) > > eligible for accelerated approval under subsection (c), as agreed upon pursuant to subsection (a)(3)(B), through, as appropriate— > > > ###### “(i) > > surrogate or intermediate endpoints reasonably likely to predict long-term clinical benefit; or > > > ###### “(ii) > > reliance upon data obtained from a meaningful number of sites, including through expansion to additional sites, as appropriate. > > > #### “(7) Postapproval requirements > > The sponsor of a regenerative advanced therapy that is granted accelerated approval and is subject to the postapproval requirements under subsection
(c)may, as appropriate, fulfill such requirements, as the Secretary may require, through— > > > ##### “(A) > > the submission of clinical evidence, clinical studies, patient registries, or other sources of real world evidence, such as electronic health records; > > > ##### “(B) > > the collection of larger confirmatory data sets, as agreed upon pursuant to subsection (a)(3)(B); or > > > ##### “(C) > > postapproval monitoring of all patients treated with such therapy prior to approval of the therapy. > > > #### “(8) Definition > > For purposes of this section, the term ‘regenerative medicine therapy’ includes cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, except for those regulated solely under section 361 of the Public Health Service Act and part 1271 of title 21, Code of Federal Regulations.” > . ###
(b)Rule of Construction **[**[21 U.S.C. 356 note](/us/usc/t21/s356)**]** Nothing in this section and the amendments made by this section shall be construed to alter the authority of the Secretary of Health and Human Services— ####
(1)to approve drugs pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and section 351 of the Public Health Service Act (42 U.S.C. 262) as authorized prior to the date of enactment of the 21st Century Cures Act, including the standards of evidence, and applicable conditions, for approval under such Acts; or ####
(2)to alter the authority of the Secretary to require postapproval studies pursuant to such Acts, as authorized prior to the date of enactment of the 21st Century Cures Act. ###
(c)Conforming Amendment Section 506(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(e)(1)) is amended by inserting “and the 21st Century Cures Act” after “Food and Drug Administration Safety and Innovation Act”.
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