OFFICE OF NEW DRUGS MODULE

Pediatric Drug Legislation

Drug Regulation

In drug regulation, pediatric patients are defined as children younger than age 17. The age cohorts are not defined in the regulations but should be based on scientific rationale -- for example, the metabolism of a critical enzyme, clinical endpoints and the ability to swallow the formulation. An example of pediatric cohorts:

• Neonates -- birth to age less than 1 month
• Infants -- age 1 month to less than 2 years
• Children -- ages 2 to less than 12 years
• Adolescents -- ages 12 to less than 17 years