Why Aren't More Pediatric Trials Performed?
Successful pediatric research requires partnership between the pharmaceutical industry, investigators, ethics committees, and parents.
Letters to the editor
Readers respond to articles and editorials.
Practical and Ethical Issues in Pediatric Clinical Trials
Both the pharmaceutical industry and regulatory authorities worldwide have recognized the need for more clinical studies in children. A recent European conference addressed the issues.
FDA, Congress Spur Pediatric Drug Development
Sponsors are underwriting more studies of children, but controversy continues over the need for FDA?s pediatric rule and the impact of extended exclusivity on generics.
Pediatric Clinical Studies in Japan: Regulations and Current Status
In Japan, pediatric clinical trials face obstacles, but new regulations give manufacturers incentive to conduct them.
No Orphans Among European Children?
The European Union is working to develop pediatric rules to ensure that medicines prescribed for children are safe, effective, and of high quality.
Ron Keeney
At work and play, he?s devoted to children.
