For the pediatric rule, does the sponsor have to address each of the pediatric age groups?
A24. A sponsor must address all of the pediatric age groups in which the drug is appropriate for use. FDA considers pediatric patients to be those aged birth up to the 16th birthday. Age categories are set as: neonates (0-1 month), infants (1 month to 2 years); children (2 years to 12 years); adolescents (12 years to 16 years). Sponsors must address the entire age range but need not necessarily use these specific age categories. If a sponsor bases its studies on characteristics other than ages, such as physiological development, the sponsor should support its categories with scientific, developmental, compliance, or ethical reasons.
