PREA requires that studies include various pediatric subpopulations, which are typically divided into the following age groups: - Neonates (birth to 1 month) - Infants (1 month to 2 years) - Children (2 to 12 years) - Adolescents (12 to 18 years)
These age groups help ensure that the drug's effects are thoroughly evaluated across the spectrum of childhood development.
