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
| 1 min read

Register for free to listen to this article
Listen with Speechify
0:00
1:00
Share

Infographic: How the Laws Work
View full size JPG | PDF
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.

Read the full story.

Interested in reading more?

Become a Member of

The Scientist Logo
Receive full access to digital editions of The Scientist, as well as TS Digest, feature stories, more than 35 years of archives, and much more!
Already a member? Login Here

Related Topics

Meet the Author

  • 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.

    View Full Profile

Published In

Share
February 2026

A Stubborn Gene, a Failed Experiment, and a New Path

When experiments refuse to cooperate, you try again and again. For Rafael Najmanovich, the setbacks ultimately pushed him in a new direction.

View this Issue
Human-Relevant In Vitro Models Enable Predictive Drug Discovery

Advancing Drug Discovery with Complex Human In Vitro Models

Stemcell Technologies
Redefining Immunology Through Advanced Technologies

Redefining Immunology Through Advanced Technologies

Ensuring Regulatory Compliance in AAV Manufacturing with Analytical Ultracentrifugation

Ensuring Regulatory Compliance in AAV Manufacturing with Analytical Ultracentrifugation

Beckman Coulter Logo
Conceptual multicolored vector image of cancer research, depicting various biomedical approaches to cancer therapy

Maximizing Cancer Research Model Systems

bioxcell

Products

Sino Biological Logo

Sino Biological Pioneers Life Sciences Innovation with High-Quality Bioreagents on Inside Business Today with Bill and Guiliana Rancic

Sino Biological Logo

Sino Biological Expands Research Reagent Portfolio to Support Global Nipah Virus Vaccine and Diagnostic Development

Beckman Coulter

Beckman Coulter Life Sciences Partners with Automata to Accelerate AI-Ready Laboratory Automation

Refeyn logo

Refeyn named in the Sunday Times 100 Tech list of the UK’s fastest-growing technology companies