Approval of pediatric exclusivity bill. (Legislative Update).On October 18, 2001, the Senate approved by voice vote a bill expanding the 1997 FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Modernization Act's pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. exclusivity rule, which was set to expire at the end of 2001. Senators Christopher Dodd Content may change as the election approaches. (D-CT) and Mike DeWine (R-OH R-OH Alcohol (chemistry) ) co-sponsored the Best Pharmaceuticals for Children Act (S. 838); it will grant drug companies conducting clinical research on a drug's efficacy in children a six-month patent extension on that drug. The bill also expands the law to include newborns, establishes an Office of Pediatric Therapeutics at the FDA and sets up a "privately funded foundation" to research other drugs that are commonly used by children. "Kids are not just miniature adults. You can't just cut a pill in half," remarked DeWine (Billings Gazette, 10/19/01). The House passed its version (H.R. 2887) on October 11, by a vote of 41-6. |
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