rare pediatric disease
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 360ff — in this section (3 versions over time)
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 of section 360bb of this title.