AAP News Vol. 13 No. 10 October 1997, p. 4
© 1997 American Academy of Pediatrics
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Pediatric drug labeling regulations advance; members' comments sought

Gem Benoza

The availability of medication approved for children took a step forward on Aug. 13 when President Clinton announced proposed Food and Drug Administration (FDA) regulations requiring pediatric studies of selected new drug and biological products.

The proposed regulation addresses the lack of clinical studies currently conducted to determine the safety and appropriate dosage levels for prescription drugs used by children. If approved, manufacturers of a limited class of new drugs and biological products will be required to provide safety and effectiveness data for relevant pediatric age groups before or soon after approval. The rule also applies to some already marketed drugs (see box below).