The FDA has issued a final regulation requiring that applications from pharmaceutical companies for new drugs and biological products contain sufficient data and information to support directions for pediatric use for the claimed indications if they (1) provide a meaningful therapeutic benefit to children or (2) are likely to be used in a substantial number of pediatric patients. The required study can be deferred until after approval if, for example, FDA finds that it is appropriate to delay pediatric studies until sufficient data are collected in adults or if imposition of the requirement would delay the availability of a new drug for adults. The requirement can also be waived if FDA finds that the product is likely to be unsafe or ineffective in pediatric patients, that pediatric studies are impossible or highly impractical, or that reasonable efforts to develop a pediatric formulation have failed.
Nightingale SL. New Rule Requires Labeling Information for Pediatric Use. JAMA. 1999;281(1):27. doi:10.1001/jama.281.1.27