How does the FDA address off-label drug use in pediatrics?
Off-label drug use refers to the prescription of medications for an age group, dosage, or condition that is not specifically approved by the FDA. While off-label use can be necessary in pediatric practice due to the limited availability of approved drugs, the FDA emphasizes the importance of using evidence-based guidelines and clinical judgment. The agency also works to expand the availability of labeled pediatric indications through programs like PREA and BPCA.
