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Journal of the National Cancer Institute Advance Access published online on January 8, 2008
JNCI Journal of the National Cancer Institute, doi:10.1093/jnci/djm317
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© Oxford University Press 2008.

NEWS

DRUGS FOR KIDS

EU Law Mandates Drug Testing in Children

Gunjan Sinha

The first 150 words of the full text of this article appear below.

When it comes to access to the latest drugs, some scientists feel that sick children get a dodgy deal. Doctors have few safety or efficacy data to guide them; most drugs are never tested in children. To plug the data gap, the European Union has revamped its drug application process.

Starting in July 2008, any company that applies to the European Medicines Agency (EMEA) to market a new drug must include a pediatric investigation plan or obtain a waiver if a drug is not suitable for children. In return, the EMEA will extend patents on new drugs by 6 months.

The new regulation, called the Pediatric Rule, doesn’t stop there. It provides funding to study off-patent drugs in children and mandates that data from all trials conducted in children be publicly available.

The regulation is modeled on a law enacted in the U.S. in 2002 that rewards companies for studying . . . [Full Text of this Article]

Medicines for Children in the U.S.

How Does Europe Compare?


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