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Example NDA submission
We have tried to provide an example of an NDA submission to help you follow the guidance document. We have provided some hypertext links between the NDA guidance document with this example and the example files. The files and folders in folder N123456 contain the following examples: · folder structure for an NDA submission · table of contents for the NDA · table of contents with bookmarks for cmc, nonclinical pharmtox, clinstat, crt, crt datasets, crt profiles, crf · table of contents for hpbio and micro (no bookmarks) · study report bookmarks (clinstat/pneumo/1234.pdf) · document information fields for labels and crf, publications (pharmtox and clinstat) · full text index (crf/crfindex.pdx) · data definition file for nonclinical data (pharmtox/datasets/101/define.pdf) · dataset for tumors from a carcinogenicity study (pharmtox/datasets/101/tumor.xpt) · data definition file for clinical data (crt/datasets/1234/define.pdf) · dataset for efficacy data (crt/datasets/1234/efficacy.xpt) · partial bookmarks for crf (crf/101/001/112.pdf) If there are any questions about these examples or the guidance documents, let us know. |
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