What pediatric studies can FDA require a company to conduct for an approved drug product?
A17. Under the rule, FDA has the authority to require pediatric studies on a drug product for the product’s approved indications IF there is SUBSTANTIAL USE in the pediatric population OR the product would provide a MEANINGFUL THERAPEUTIC BENEFIT – AND the absence of adequate labeling could pose significant risk (see 21 CFR 201.23(a)). At this time, however, FDA will not require studies of approved drugs except if approved by the Center Director. Instead, FDA will seek to have manufacturers voluntarily submit studies for marketed drugs under the incentives provided by FDAMA (see 63 FR 66634 Sec II). For those drugs in which voluntary measures fail to obtain necessary pediatric studies, FDA will consider requiring studies.
