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NETS - Unapproved Compounds

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What are unapproved compounds and why are they important in drug development?

Unapproved compounds are drugs or small molecules that have not received FDA approval for use in humans. Preclinical and clinical studies are needed to determine whether an unapproved compound is safe to test in humans. Unapproved compounds may be classified as new chemical entities (NCE) or new molecular entities (NME). Both contain novel active moieties (the part of the compound that gives the specific physiological or pharmacological function).

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