New Drug Application (NDA)
NDAThe formal submission to the FDA requesting approval to market a new pharmaceutical. Contains full clinical trial data, manufacturing information, labeling, and safety data from Phase I-III trials.
ตัวอย่าง
- 505(b)(1) full NDA
- 505(b)(2) referencing existing data
- Priority vs standard review
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The formal submission to the FDA requesting approval to market a new pharmaceutical. Contains full clinical trial data, manufacturing information, labeling, and safety data from Phase I-III trials.