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. 

By Bob Grant | March 1, 2012

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.

Add a Comment

Avatar of: You

You

Processing...
Processing...

Sign In with your LabX Media Group Passport to leave a comment

Not a member? Register Now!

LabX Media Group Passport Logo

Popular Now

  1. DNA Robots Target Cancer
    Daily News DNA Robots Target Cancer

    Researchers use DNA origami to generate tiny mechanical devices that deliver a drug that cuts off the blood supply to tumors in mice.

  2. Stem Cell Vaccine Protects Mice From Cancer
  3. Love in the Scientific Literature
    News Analysis Love in the Scientific Literature

    There are countless ways for scientists to say, “I love you.” Naming a slime-mold beetle after your wife (and another after your ex-wife) is, apparently, one of them.  

  4. Gene Expression Overlaps Among Psychiatric Disorders
AAAS