new drug
noun Date: circa 1951 a drug that has not been declared safe and effective by qualified experts under the conditions prescribed, recommended, or suggested in the label and that may be a new chemical formula or an established drug prescribed for use in a new way

New Collegiate Dictionary. 2001.

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  • investigational new drug — in·ves·ti·ga·tion·al new drug in .ves ti gā shə nəl n a drug that has not been approved for general use by the Food and Drug Administration but is under investigation in clinical trials regarding its safety and efficacy first by clinical… …   Medical dictionary

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