AAP News Vol. 14 No. 7 July 1998, p. 4
© 1998 American Academy of Pediatrics
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Pediatric drug list

Marjorie Tharp

On May 20, the Food and Drug Administration (FDA) issued its list of more than 500 drugs for which additional pediatric information might produce health benefits in infants, children and adolescents. In issuing the list, the FDA embraced a concept long-sought by the Academy: that all drugs be studied in children if the disease targeted by the drug occurs in children.

The list was developed in response to a law signed last November called the "Food and Drug Administration Modernization and Accountability Act" (PL 105-115). The law encourages drug companies to conduct pediatric studies of drugs and offers six months of market exclusivity to new and already marketed drugs for which the U.S. Department of Health and Human Services (HHS) secretary makes a written request for pediatric studies.