Glossary / Regulatory / FDA-approved

FDA-approved

A product the FDA has reviewed and authorized for a specific use. Approval attaches to a specific product and indication, not to a molecule in general. Material sold outside the approved supply chain is not the approved product, regardless of labeling.

A product the FDA has reviewed and authorized for a specific use. Approval attaches to a specific product and indication, not to a molecule in general. Material sold outside the approved supply chain is not the approved product, regardless of labeling.

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