| 2nd February 2013 04:41 PM | |
| Arvind Kumar | Re: NDA submission requirements I am here by providing you the ZIP file that contain the sample NDA Submission. This ZIP file contain • 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) |
| 31st January 2013 01:18 PM | |
| madmankart | NDA submission requirements NDA submission requirements Please provide me the NDA Submission Requirement. |
