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FDA Issues Guidance To Protect Children Enrolled in Clinical Trials

 
• By Brian Bossetta

The US FDA has published a draft guidance outlining its current thinking on ethical considerations for clinical trials of medical products, including devices, that enroll children.

FDA Blocks Fire Truck
• Source: Shutterstock

The US Food and Drug Administration has issued a draft guidance to assist stakeholders enrolling children in clinical trials of medical products, including devices, drugs and biologics.

The guidance, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children,” is scheduled for publication in the Federal...

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