rare pediatric disease
Defined in 1 place of the United States Code.
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.
Source
- 2016–present21 U.S.C. § 360ffFood and Drugs · Priority review to encourage treatments for rare pediatric diseases · in this section
The term “rare pediatric disease” means a disease that meets each of the following criteria:
(A) The disease primarily affects 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.
Source
- 2012–201621 U.S.C. § 360ffFood and Drugs · Priority review to encourage treatments for rare pediatric diseases · in this section