Dossier DOS-090

Dossier in NeeS format, version 2.6.2, for application MFDS-2020-0090. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-090
Format
NeeS
Version
2.6.2
Status
Failed
Application
MFDS-2020-0090
Created
2023-02-05
Updated
2024-06-18
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information15Approved
2CTD Summaries6Blocked
3Quality9In Progress
4Nonclinical Study Reports4Pending
5Clinical Study Reports8Active
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0901.2.6Application Form4.5XML5,603In ProgressJames O'Brien
CC-1902.5.7Nonclinical Overview10.8XML9,844PendingNadia Petrova
CC-2905.6.7Study Reports – Clinical Pharmacology5.5HTML1,810SubmittedSarah Chen
CC-3905.3.6Integrated Summary of Efficacy7.3XML11,375BlockedJames O'Brien
CC-4904.1.1Pharmacology Studies1.3PDF3,367BlockedSarah Chen
CC-5902.6.2Quality Overall Summary3.6XML6,585ApprovedLieselotte van der Berg
CC-6905.7.6Study Reports – Clinical Pharmacology7.4Word13,463SubmittedAisha Okonkwo
CC-7901.6.6Proposed Conditions of Approval11.7XML1,752SubmittedSarah Chen
CC-8905.6.4Integrated Summary of Efficacy3.6XML6,295DraftAisha Okonkwo
CC-9905.1.9Study Reports – Safety1.8PDF14,961ApprovedJames O'Brien
CC-10905.9.7Integrated Summary of Efficacy9.5HTML14,328DraftSarah Chen
CC-11903.1.1Manufacturing Process4.7HTML4,545OverdueSarah Chen
CC-12905.9.6Integrated Summary of Safety3.2XML8,561BlockedLieselotte van der Berg
CC-13903.8.4Analytical Methods2.4HTML12,193BlockedMarcus Webb
CC-14905.8.4Integrated Summary of Efficacy7.3HTML3,755OverdueNadia Petrova
CC-15901.4.8Prescribing Information1.3HTML2,709OverdueNadia Petrova
CC-16904.4.9Pharmacology Studies5.4XML6,447SubmittedNadia Petrova
CC-17904.9.5Pharmacology Studies6.0PDF11,198DraftNadia Petrova
CC-18902.6.3Nonclinical Overview6.0XML8,494In ProgressTomoko Ikeda
CC-19901.8.7Application Form11.9Word7,245FailedMarcus Webb