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USFDA Guidance: Clinical Investigations of Medical Products Involving Children

A draft guidance was released on 23 September 2022 by the US Food and Drug Administration on the ethical considerations for including and protecting children in clinical trials, which will be finalized soon.


Drugs, Biological Products, and Medical devices are collectively referred to as “Medical Products”. This draft guidance aims to assist industry, sponsors, and institutional review boards (IRBs) when considering enrolling children in clinical trials.


A clinical study involving children must provide additional safeguards since children are vulnerable and cannot consent on their own. According to this guidance, the FDA considers ethical considerations when conducting therapeutic trials in children.


Institutional review boards (IRBs) are required to follow these regulations and in 21 CFR parts, 50 and 56; additional safeguards for children are included in 21 CFR part 50, subpart D when reviewing clinical investigations of FDA-regulated medical products that are intended to enroll children.


Click this LINK to know more about this guidance "Ethical Considerations for Clinical Investigations of Medical Products Involving Children".



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