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Non-Approved Substances

Meaning

Non-Approved Substances, in a clinical and regulatory context, refers to medicinal agents, compounds, or therapies that have not received formal authorization or clearance from national or international regulatory bodies, such as the FDA or EMA, for clinical use or marketing. This classification typically applies to substances that are still undergoing investigation, lack sufficient evidence of safety and efficacy, or are being used off-label without proper oversight. Their use carries significant risk and falls outside the standard of evidence-based medical practice.