new drug application (NDA) → αίτηση νέου φαρμάκου

spiros

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new drug approval (NDA) → έγκριση νέου φαρμάκου
new drug submission (NDS) → υποβολή νέου φαρμάκου
new drug application (NDA) → αίτηση νέου φαρμάκου

The Food and Drug Administration (FDA)'s New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful.
New Drug Application - Wikipedia


 

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