AAP News Vol. 13 No. 12 December 1997, p. 1
© 1997 American Academy of Pediatrics
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Pediatric drug labeling bill passes

The wait is over and the news is good. On Nov. 9, the House and Senate passed legislation which includes a hard-fought win for children.

Within the Food and Drug Administration (FDA) Modernization and Accountability Act of 1997 (S. 830) is an AAP-backed component that will request drug companies to conduct clinical studies in children for new drugs and drugs already on the market, in exchange for six months market exclusivity. This provision expires on Jan. 1, 2002.