News of the WeekPEDIATRIC DRUG TRIALS

Challenge to FDA's Authority May End Up Giving It More

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Science  03 May 2002:
Vol. 296, Issue 5569, pp. 820-821
DOI: 10.1126/science.296.5569.820

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Summary

In a recent 4-week period, the U.S. government reversed course twice on whether drugmakers should be compelled to test their products on children. The muddle ended 19 April when the Bush Administration came out in favor of retaining a 3-year-old rule that gives the Food and Drug Administration (FDA) power to demand that companies conduct targeted studies to learn about side effects and set proper doses for children. Several senators responded this week by proposing to give FDA permanent authority to order such clinical trials.

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