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Non-FDA-approved Agent Ethics

Meaning

Non-FDA-approved Agent Ethics is the specialized branch of clinical bioethics that governs the responsible, transparent, and patient-centered use of substances that have not undergone the formal approval process of the Food and Drug Administration. This framework mandates that clinicians prioritize patient safety, ensure rigorous informed consent, and maintain scientific integrity when utilizing compounded agents, certain peptides, or specific off-label pharmacological uses. It addresses the moral obligation to balance therapeutic innovation with the absence of standard regulatory oversight.