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. 

Bob Grant
Bob Grant

Bob started with The Scientist as a staff writer in 2007. Before joining the team, he worked as a reporter at Audubon and earned a master’s degree in science journalism...

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Mar 1, 2012

Infographic: How the Laws Work
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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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