Rare Pediatric Disease definition

Rare Pediatric Disease means a disease that meets each of the following criteria: (A) The disease is a serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents; (B) The disease is a rare disease or condition, within the meaning of 21 USC § 360bb.
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Rare Pediatric Disease means rare pediatric disease as defined in Section 529(a)(3) of the FFDCA.
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Rare Pediatric Disease means a disease that meets each of the following criteria:
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Examples of Rare Pediatric Disease in a sentence

  • Letterhead] Priority Review Voucher TransferMay __, 2024 [●] Re: Ojemda (tovorafenib) Tablet NDA 217700, SN:[●] Transfer of Rare Pediatric Disease Priority Review Voucher PRV NDA 217700 Dear [●]: Reference is made to the New Drug Application (NDA) 217700, the approval letter dated April 23, 2024 (the “Approval Letter”) (Ref ID: 5368906) reflecting the grant of the Rare Pediatric Disease Priority Review Voucher PRV NDA 217700 (the “Voucher”) to Day One Biopharmaceuticals, Inc.

  • Letterhead] May 29, 2024 [*] Re: NDA 217700 – Transfer of Rare Pediatric Disease Priority Review Voucher PRV NDA 217700 (the “Voucher”) Dear Sir or Madam: Reference is made to the above-referenced NDA approval letter dated April 23, 2024 reflecting the grant of the Voucher to Day One Biopharmaceuticals, Inc.

Related to Rare Pediatric Disease

  • muscular dystrophy means a group of hereditary genetic muscle disease that weakens the muscles that move the human body and persons with multiple dystrophy have incorrect and missing information in their genes, which prevents them from making the proteins they need for healthy muscles. It is characterised by progressive skeletal muscle weakness, defects in muscle proteins, and the death of muscle cells and tissue;

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Iatrogenic infertility means an impairment of fertility by surgery, radiation, chemotherapy, or other medical treatment affecting reproductive organs or processes.