The US commons and Drug Administra...

The US commons and Drug Administration (FDA) has announced final regulations forward the safe and appropriate use of just discovered medications and biologics in children, according to a Nov 27 1998 pres release from the FDA. The regulations, which will be provided to health care practitioners, require that recently made known medications and biologics that are therapeutically important for children, or will be commonly used in children, have labeling information in succession safe pediatric use.

According to the release, each year more than half of newly approved medications and biologics that are likely to be used in children lack information to permit safe and effective use. Without adequate information, physicians may be reluctant to prescribe certain medications for their pediatric patients or may prescribe them inappropriately. The just discovered regulations make it more likely that children will receive improved treatment because physicians will have more perfect information on how medications affect children and what age-appropriate doses are urgencyed according to the release.

FDA Acts to Make unsalable articles Safer for Children (press release, Washington, DC: US provender and Drug Administration, US Deportment of Health and Human Services, Nov 27 1998) 1-2

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