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Article | February 28, 2006
Milestone for pediatric drug labeling
There are now 100 pediatric drugs that contain additional labeling information on safety, efficacy, dosing, and unique risks for children.
The amended Federal Food Drug and Cosmetic Act of 1997 and the 2002 Best Pharmaceuticals for Children Act provide incentives for drug manufacturers to conduct research to obtain such information based on the same level of scientific evidence required for adults. The result has been a 20-fold increase in pediatric studies.
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