How the Pediatric Laws Work

The Pediatric Research Equity Act (PREA) of 2003 requires that companies developing new drugs that could be used to treat a condition in children perform clinical trials in kids before winning FDA approval.

Written byBob Grant
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MATT COLLINS (BABY); US GOVERNMENT ACCOUNTABILITY OFFICE REPORT, "PEDIATRIC RESEARCH," MAY 2011

The Pediatric Research Equity Act (PREA) of 2003 requires that companies developing new drugs that could be used to treat a condition in children perform clinical trials in kids before winning FDA approval. The Best Pharmaceuticals for Children Act (BPCA) of 2002 offers financial incentives for companies to test drugs, either pre- or post-approval, in pediatric trials deemed necessary by the FDA.

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  • From 2017 to 2022, Bob Grant was Editor in Chief of The Scientist, where he started in 2007 as a Staff Writer. Before joining the team, he worked as a reporter at Audubon and earned a master’s degree in science journalism from New York University. In his previous life, he pursued a career in science, getting a bachelor’s degree in wildlife biology from Montana State University and a master’s degree in marine biology from the College of Charleston in South Carolina. Bob edited Reading Frames and other sections of the magazine.

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