Adding Pediatric Studies to New Drug Development A Guide to US and EU Rules
New guidances in the US and EU require drugmakers to include a pediatric component in clinical trials for any new drug that could be used to treat children as well as adults.
Most drug researchers don’t study the potential effects the product could have on children. How can you integrate pediatric studies with your more adult-focused clinical trials?
This report explains the process to follow in both the US and EU as well as requirements outlined in recent FDA draft guidance and European Commission guidelines. It also discusses:
How to get a priority review voucher
How to get a waiver or deferral
The kinds of incentives regulators are offering drugmakers to conduct pediatric research
How Canada, Japan and Switzerland are addressing the pediatric research issue
Potential future developments
Stay on top of new pediatric research regulations. Order your copy of Adding Pediatric Studies to New Drug Development: A Guide to US and EU Rules today.
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Note: This publication will be available in PDF format by Nov. 9, 2016.
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