While PREA has made significant strides, there are still limitations:
1. Exemptions: Certain drugs, such as those for rare diseases or conditions primarily affecting adults, may be exempt from pediatric study requirements. 2. Delayed Studies: Companies can request deferrals for pediatric studies, leading to delays in the availability of pediatric data. 3. Limited Scope: PREA does not cover all therapeutic areas equally, leaving gaps in pediatric research for certain conditions.
