Term
| How do you define a new drug? |
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Definition
It is an article intended for:
-diagnosis
-cure
-mitigation
-treatment
or Prevention of disease in Humans OR animals |
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Term
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Definition
-New chemical entity
-New formulation
-New combination
-New use |
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Term
| HPUS Definition of a new drug |
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Definition
| A new drug is any that is not recognized as being safe and effective in the conditions recommended for its use among experts |
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Term
| Which is higher risk, Type 1 or Type 6 drugs? |
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Definition
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Term
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Definition
| New molecular entity, not marketed in the US |
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Term
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Definition
| New ester, salt, or derivative of an approved moiety |
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Term
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Definition
| New Formulation of a drug markted in the US |
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Term
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Definition
| New Combination of two or more compounds |
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Term
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Definition
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Term
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Definition
| New therapeutic indication |
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Term
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Definition
-Emperical formula
-Code name by inventer
-Nonpropriety (generic) name by USAN
-Proprietary name (for patents) |
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