Ethical Considerations for Clinical Investigations of Medical Products Involving Children; Draft Guidance for Industry, Sponsors, and Institutional Review Boards; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, sponsors, and institutional review boards (IRBs) entitled "Ethical Considerations for Clinical Investigations of Medical Products Involving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 This draft guidance describes FDA's current thinking regarding ethical considerations for clinical investigations of drugs, biological products, and medical devices (collectively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 The draft guidance is intended to assist industry, sponsors, and IRBs when considering the enrollment of children in clinical investigations of medical products.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.