| new drug application |
An application requesting FDA approval to market a new drug for human use in interstate commerce. The application must contain, among other things, data from specific technical viewpoints for FDA review--including chemistry, pharmacology, medical, biopharmaceutics, statistics, and, for anti-infectives, microbiology.
출처: www.fda.gov/fdac/special/newdrug/bengloss.html
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| new drug application |
following phase III of clinical testing, the drug sponsor applies for a new drug application, which is reviewed by the FDA. If the FDA finds the results favorable, the drug company can market the drug for conditions/ diseases, which are applicable to phase testing results.
출처: www.therubins.com/geninfo/Definit.htm
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| new drug application |
ABBR: NDA. An application requiring approval by the Food and Drug Administration before any new drug is marketed to the general public. Before approval, the manufacturer must provide the FDA with scientifically acceptable e
출처:
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| new drug application |
Sponsors file an NDA with the FDA upon completion of testing, requesting approval to market the drug.
출처: www.ccfa.org/trials/glossary
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