Ethical Considerations for Clinical Investigations of Medical Products Involving Children; Draft Guidance for Industry, Sponsors, and Institutional Review Boards; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, sponsors, and institutional review boards (IRBs) entitled "Ethical Considerations for Clinical Investigations of Medical Products Involving Children." This draft guidance describes FDA's current thinking regarding ethical considerations for clinical investigations of drugs, biological products, and medical devices (collectively referred to as "medical products" in this notice) involving children. The draft guidance is intended to assist industry, sponsors, and IRBs when considering the enrollment of children in clinical investigations of medical products.