rare pediatric disease

(3)The term “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 ofsection 360bb of this title.


21 USC § 360ff(a)(3)

Scoping language

In this section
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