Sec. 2. Drug development for pediatric cancer
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Section 505B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c ) is amended— in subsection (a)(2)(A)(i) by striking product for the claimed indications in all relevant pediatric subpopulations; and and inserting “product in all relevant pediatric subpopulations— for the claimed indications; or ; for a pediatric cancer indication, if the drug is intended for the treatment of an adult cancer and is directed at a molecular target considered to be germane to the growth and progression of such pediatric cancer; and ; in subsection (b)(1)— by amending subparagraph (A)(i) to read as follows: the drug or biological product is used for a substantial number of pediatric patients— for the labeled indications; or for a pediatric cancer indication, if the drug is intended for the treatment of an adult cancer and is directed at a molecular target considered to be germane to the growth and progression of such pediatric cancer; and ; and by amending subparagraph
(B)to read as follows: there is reason to believe that the drug or biological product would represent a meaningful therapeutic benefit over existing therapies for pediatric patients— for one or more of the claimed indications; or for a pediatric cancer indication, if the drug is intended for the treatment of an adult cancer and is directed at a molecular target considered to be germane to the growth and progression of such pediatric cancer; or ; and by amending paragraph
(2)of subsection
(c)to read as follows: the drug or biological product is in a class of products, is for an indication, or is directed at a specific molecular target in an adult cancer and such molecular target is germane to the growth or progression of cancer in a pediatric cancer, for which there is need for additional options. . Clause
(i)of section 505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c(e)(2)(C) ) is amended to read as follows: shall meet with the applicant— if requested by the applicant with respect to a drug that is intended to treat a serious or life-threatening disease or condition, to discuss preparation of the initial pediatric study plan, not later than the end-of-Phase 1 meeting (as such term is used in section 312.47(b) of title 21, Code of Federal Regulations, or successor regulations) or within 30 days of receipt of such request, whichever is later; to discuss the initial pediatric study plan as soon as practicable, but not later than 90 calendar days after the receipt of such plan under subparagraph (A); and to discuss any scientific or operational challenges that may be the basis of a deferral under subsection (a)(3) or a full or partial waiver under subsection (a)(4); . Section 505B(e) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c(e) ) is amended— in the heading of paragraph (2), by striking and inserting meeting ; meetings in the heading of paragraph (2)(C), by striking and inserting Meeting ; Meetings in clauses
(ii)and
(iii)of paragraph (2)(C), by striking no meeting each place it appears and inserting no meeting under clause (i)(II) ; and in paragraph
(3)by striking meeting under paragraph (2)(C)(i) and inserting meeting under paragraph (2)(C)(i)(II) . Section 505B(k) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c(k) ) is amended by inserting except in the case of a drug or biological product that is intended for the treatment of an adult cancer and is directed at a molecular target considered to be germane to the growth and progression of a pediatric cancer, after regulation, . Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue guidance on the implementation of the amendments to section 505B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c ) made by this section, including— study designs; molecular targets considered to be germane to the growth and progression present in one or more cancers in pediatric populations that may be appropriate for assessment under such section 505B, as so amended; and considerations for implementation of such section 505B, as so amended, and waivers of the requirements of such section 505B with regard to molecular targets for which several drugs may be under investigation. This section and the amendments made by this section apply with respect to applications for a drug submitted under section 505 of the Federal Food, Drug, or Cosmetic Act ( 21 U.S.C. 355 ) or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) on or after the date that is 18 months after the date of enactment of this Act. Section 508(b) of the FDA Safety and Innovation Act ( 21 U.S.C. 355c–1(b) ) is amended— in paragraph (10), by striking ; and and inserting ; ; and by striking paragraph
(11)and inserting the following: an assessment of the impact of the amendments to such section 505B made by the RACE for Children Act on pediatric labeling of drugs and pediatric labeling of molecularly targeted drugs for the treatment of cancer; an assessment of the efforts of the Secretary to implement the plan developed under section 505C–1 of the Federal Food, Drug, and Cosmetic Act, regarding earlier submission of pediatric studies under sections 505A and 505B, including— the average length of time after the approval of an application under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b)(1) ) before studies conducted pursuant to such sections 505A or 505B are completed, submitted, and incorporated into labeling; the average length of time after the receipt of a proposed pediatric study request before the Secretary responds to such request; the average length of time after the submission of a proposed pediatric study request before the Secretary issues a written request for such studies; the number of written requests issued for each investigational new drug prior to the submission of an application under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act; and the average number, and range of numbers, of amendments to written requests issued; a list of sponsors of applications or holders of approved applications who received exclusivity under such section 505A after receiving a letter issued under such section 505B(d)(1) and before the studies referred to in such letter were completed and submitted; and a list of assessments required under subsection (a)(2)(A)(i)(II), and (b)(1)(B)(ii) of section 505B. . Nothing in this section, including the amendments made by this section, shall limit the authority of the Secretary of Health and Human Services to issue written requests under section 505A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355a ).
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- 21 USC 355c–1(b)
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Sec. 2
Drug development for pediatric cancer
Cite21 USC 355c–1(b)
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