21 U.S.C. 355c: Research into pediatric uses for drugs and biological products

2022

• Pub. L. 117–328 substituted "subsection (a)(4)(C)" for "subsection (a)(3)(B)". (Consolidated Appropriations Act, 2023) Law text · (f)

2017

• Pub. L. 115–52, §504(a)(1)(A), designated existing provisions as subpar. (A) and inserted heading, substituted "Except with respect to an application for which subparagraph (B) applies, a person" for "A person", redesignated former subpars. (A) and (B) as cls. (i) and (ii), respecti… (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §504(a)(1)(B), substituted "paragraph (1)(A)" for "paragraph (1)" in introductory provisions. (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §504(a)(1)(D), added par. (3). Former par. (3) redesignated (4). (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §504(a)(1)(C), redesignated par. (3) as (4). Former par. (4) redesignated (5). (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §504(a)(1)(E)(i), substituted "assessments required under paragraph (1)(A) or reports on the investigation required under paragraph (1)(B)" for "assessments required under paragraph (1)" in introductory provisions. (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §504(a)(1)(E)(ii), inserted "or reports on the investigation" after "assessments". (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §504(a)(1)(E)(i), substituted "assessments required under paragraph (1)(A) or reports on the investigation required under paragraph (1)(B)" for "assessments required under paragraph (1)" in introductory provisions. (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §504(a)(1)(E)(iii), substituted "assessment under paragraph (1)(A) or reports on the investigation under paragraph (1)(B)" for "assessment under paragraph (1)". (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §504(a)(1)(E)(iv), inserted "or investigation" after "assessment". (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §504(a)(1)(C), redesignated par. (4) as (5). (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §504(a)(1)(F), inserted "or reports on the investigation" after "assessments" in introductory provisions. (FDA Reauthorization Act of 2017) Law text · (a), (B)
• Pub. L. 115–52, §504(a)(2), inserted "and reports on the investigation" after "Submission of assessments" in heading and, in introductory provisions, inserted "or the investigation described in subsection (a)(3)" after "assessment described in subsection (a)(2)" and substituted "subsec… (FDA Reauthorization Act of 2017) Law text · (d)
• Pub. L. 115–52, §505(e), inserted at end "The Secretary shall inform the Pediatric Advisory Committee of letters issued under this paragraph and responses to such letters." (FDA Reauthorization Act of 2017) Law text · (d)
• Pub. L. 115–52, §504(a)(2)(A), (C), in introductory provisions, inserted "or the investigation described in subsection (a)(3)" after "assessment described in subsection (a)(2)" and substituted "subsection (a)(4)" for "subsection (a)(3)". (FDA Reauthorization Act of 2017) Law text · (d)
• Pub. L. 115–52, §504(a)(3)(A), inserted "or the investigation described in subsection (a)(3)" after "under subsection (a)(2)". (FDA Reauthorization Act of 2017) Law text · (e)
• Pub. L. 115–52, §503(b)(1), substituted "meetings" for "meeting" in heading. (FDA Reauthorization Act of 2017) Law text · (e)
• Pub. L. 115–52, §504(a)(3)(B), inserted "or the investigation described in subsection (a)(3)" after "under subsection (a)(2)". (FDA Reauthorization Act of 2017) Law text · (e)
• Pub. L. 115–52, §503(b)(2), substituted "Meetings" for "Meeting" in heading. (FDA Reauthorization Act of 2017) Law text · (e)
• Pub. L. 115–52, §503(a), amended cl. (i) generally. Prior to amendment, cl. (i) read as follows: "shall meet with the applicant 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 subparag… (FDA Reauthorization Act of 2017) Law text · (e)
• Pub. L. 115–52, §503(b)(3), substituted "no meeting under clause (i)(II)" for "no meeting". (FDA Reauthorization Act of 2017) Law text · (e), (iii)
• Pub. L. 115–52, §503(b)(4), substituted "meeting under paragraph (2)(C)(i)(II)" for "meeting under paragraph (2)(C)(i)". (FDA Reauthorization Act of 2017) Law text · (e)
• Pub. L. 115–52, §504(b), amended subsec. (k) generally. Prior to amendment, text read as follows: "Unless the Secretary requires otherwise by regulation, this section does not apply to any drug for an indication for which orphan designation has been granted under section 360bb of this … (FDA Reauthorization Act of 2017) Law text · (k)
• Pub. L. 115–52, §504(a)(4), added subsec. (m). (FDA Reauthorization Act of 2017) Law text · (m)

2016

• Pub. L. 114–255, §3101(a)(2)(D)(i)(I)(aa), inserted "study" after "initial pediatric" in introductory and concluding provisions. (21st Century Cures Act) Law text · (e)
• Pub. L. 114–255, §3101(a)(2)(D)(i)(I)(bb), substituted "Content of initial pediatric study plan" for "Content of initial plan" in heading. (21st Century Cures Act) Law text · (e)
• Pub. L. 114–255, §3101(a)(2)(D)(i)(II), inserted "agreed initial pediatric study" before "plan" in heading. (21st Century Cures Act) Law text · (e)
• Pub. L. 114–255, §3101(a)(2)(D)(i)(III), substituted "agreed initial pediatric study plan" for "agreed initial pediatric plan". (21st Century Cures Act) Law text · (e)
• Pub. L. 114–255, §3101(a)(2)(D)(ii), inserted "and any significant amendments to such plans," after "agreed initial pediatric study plans,". (21st Century Cures Act) Law text · (f)
• Pub. L. 114–255, §3102(3), redesignated subsec. (m) as (l) and struck out former subsec. (l) which related to Institute of Medicine study. (21st Century Cures Act) Law text · (l), (m)

2012

• Pub. L. 112–144, §509(b)(1)(A), inserted "for a drug" after "(or supplement to an application)" in introductory provisions. (Food and Drug Administration Safety and Innovation Act) Law text · (a)
• Pub. L. 112–144, §506(b)(1), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: "a description of the planned or ongoing studies;". (Food and Drug Administration Safety and Innovation Act) Law text · (a)
• Pub. L. 112–144, §505(a)(1)(A), (B), added subpar. (B) and redesignated former subpar. (B) as (C). (Food and Drug Administration Safety and Innovation Act) Law text · (a), (C)
• Pub. L. 112–144, §505(a)(1)(C)(i), added subcls. (III) and (IV). (Food and Drug Administration Safety and Innovation Act) Law text · (a), (IV)
• Pub. L. 112–144, §505(a)(1)(C)(ii), amended cl. (ii) generally. Prior to amendment, text read as follows: "The information submitted through the annual review under clause (i) shall promptly be made available to the public in an easily accessible manner, including through the… (Food and Drug Administration Safety and Innovation Act) Law text · (a)
• Pub. L. 112–144, §509(b)(1)(B), inserted "partial" after "If a" in first sentence and substituted "such a" for "either a full or" in second sentence. (Food and Drug Administration Safety and Innovation Act) Law text · (a)
• Pub. L. 112–144, §509(b)(2), substituted "The" for "After providing notice in the form of a letter (that, for a drug approved under section 355 of this title, references a declined written request under section 355a of this title for a labeled indication which written request is not… (Food and Drug Administration Safety and Innovation Act) Law text · (b)
• Pub. L. 112–144, §505(c)(1), amended subsec. (d) generally. Prior to amendment, subsec. (d) related to submission of assessments. (Food and Drug Administration Safety and Innovation Act) Law text · (d)
• Pub. L. 112–144, §506(a), amended subsec. (e) generally. Prior to amendment, text read as follows: "Before and during the investigational process for a new drug or biological product, the Secretary shall meet at appropriate times with the sponsor of the new drug or biological product t… (Food and Drug Administration Safety and Innovation Act) Law text · (e)
• Pub. L. 112–144, §506(b)(2)(A), substituted "pediatric study plans," for "pediatric plans," in heading. (Food and Drug Administration Safety and Innovation Act) Law text · (f)
• Pub. L. 112–144, §505(a)(2)(A), inserted "deferral extensions," after "deferrals," in heading. (Food and Drug Administration Safety and Innovation Act) Law text · (f)
• Pub. L. 112–144, §506(b)(2)(B), substituted "initial pediatric study plans, agreed initial pediatric study plans," for "all pediatric plans". (Food and Drug Administration Safety and Innovation Act) Law text · (f)
• Pub. L. 112–144, §505(a)(2)(B), inserted ", deferral extension," after "deferral". (Food and Drug Administration Safety and Innovation Act) Law text · (f)
• Pub. L. 112–144, §506(b)(2)(C), substituted "pediatric study plans," for "pediatric plans," in heading and "initial pediatric study plans, agreed initial pediatric study plans," for "pediatric plans" in text. (Food and Drug Administration Safety and Innovation Act) Law text · (f)
• Pub. L. 112–144, §505(a)(2)(C), inserted "deferral extensions," after "deferrals," in heading and ", deferral extensions," after "deferrals" in text. (Food and Drug Administration Safety and Innovation Act) Law text · (f)
• Pub. L. 112–144, §505(b), amended subpar. (D) generally. Prior to amendment, subpar. (D) read as follows: "the total number of deferrals requested and granted under this section and, if granted, the reasons for such deferrals, the timeline for completion, and the number completed… (Food and Drug Administration Safety and Innovation Act) Law text · (f)
• Pub. L. 112–144, §505(c)(2), added cl. (iv). (Food and Drug Administration Safety and Innovation Act) Law text · (f)
• Pub. L. 112–144, §509(b)(3)(A), inserted "that receives a priority review or 330 days after the date of the submission of an application or supplement that receives a standard review" after "after the date of the submission of the application or supplement" in introductory provis… (Food and Drug Administration Safety and Innovation Act) Law text · (g)
• Pub. L. 112–144, §509(b)(3)(B), substituted "the labeling of such product" for "the label of such product". (Food and Drug Administration Safety and Innovation Act) Law text · (g)
• Pub. L. 112–144, §509(b)(4), inserted "an application (or supplement to an application) that contains" after "date of submission of" and "if the application (or supplement) receives a priority review, or not later than 330 days after the date of submission of an application (or supp… (Food and Drug Administration Safety and Innovation Act) Law text · (h)
• Pub. L. 112–144, §509(b)(5)(A), substituted "first 18-month period" for "year one" in heading and "18-month" for "one-year" in text. (Food and Drug Administration Safety and Innovation Act) Law text · (i)
• Pub. L. 112–144, §509(b)(5)(B), substituted "periods" for "years" in heading and "18-month period" for "one-year period" in text. (Food and Drug Administration Safety and Innovation Act) Law text · (i)
• Pub. L. 112–144, §509(b)(5)(C), (D), added par. (3) and redesignated former par. (3) as (4). (Food and Drug Administration Safety and Innovation Act) Law text · (i), (4)
• Pub. L. 112–144, §501(b), redesignated subsec. (n) as (m) and struck out former subsec. (m). Prior to amendment, text of subsec. (m) read as follows: "The authority under this section shall remain in effect so long as an application subject to this section may be accepted for fil… (Food and Drug Administration Safety and Innovation Act) Law text · (m), (n)

2010

• Pub. L. 111–148 added subsec. (n). (Patient Protection and Affordable Care Act) Law text · (n)

2007

• Pub. L. 110–85 amended section generally. Prior to amendment, section related to required submission of assessments with an application for a new drug or new biological product and by order of the Secretary for certain marketed drugs and biological products used for pediatric patients, a definition… (Food and Drug Administration Amendments Act of 2007) Law text