New Drug Application
NDADefinisi
The formal request submitted to the FDA by a pharmaceutical company to gain approval to market a new drug in the United States. An NDA contains comprehensive data on the drug's chemistry, manufacturing, pharmacology, clinical trials, and proposed labeling. The review process typically takes 10-12 months.
Contoh
After completing Phase III trials showing efficacy and safety, the manufacturer files an NDA. If approved, the drug can be marketed and prescribed.
Istilah Terkait
Disebutkan dalam Panduan
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