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U.S. Pediatric Studies Have Led to New Labeling for Nearly 100 Drugs, According to Tufts Center for the Study of Drug Development
The FDA Modernization Act of 1997 granted pharmaceutical companies that conducted FDA requested studies of their medicines in children an additional 6 months of exclusivity after patent expiration—i.e., it granted companies protection from generic competitors for an additional 6 months. It was hoped that the patent extension would encourage companies to study the effects of their drugs in children, since drugs can have very different effects in the adult and pediatric populations.
The Tufts University Center for the Study of Drug Development conducted an analysis of the effect that this incentive has had on pediatric studies for drugs and found that:
Nearly 100 medicines for sale in the United states have received pediatric labeling since the late 1990s based on new clinical studies to determine appropriate dosages, safety, efficacy, and formulations for children…
“The increase in pediatric labeling signals a major advance in pediatric medicine,” said Christopher Milne, assistant director of Tufts CSDD and author of the study. “This will improve the overall health of children, who comprise 25% of the U.S. population.”
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