Dossier DOS-010

Dossier in CTD format, version 5.4.8, for application MFDS-2020-0010. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-010
Format
CTD
Version
5.4.8
Status
In Progress
Application
MFDS-2020-0010
Created
2022-12-14
Updated
2023-06-30
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information10Overdue
2CTD Summaries3Approved
3Quality13Blocked
4Nonclinical Study Reports12Approved
5Clinical Study Reports12Overdue
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0105.4.1Integrated Summary of Safety5.9Word8,996In ProgressMarcus Webb
CC-1105.8.2Integrated Summary of Safety6.2Word12,111DraftCarlos Mendez
CC-2104.5.8Carcinogenicity1.1HTML6,271OverduePriya Sharma
CC-3105.9.9Study Reports – Efficacy8.4XML13,213In ProgressLieselotte van der Berg
CC-4101.9.2Cover Letter11.5Word8,870In ProgressPriya Sharma
CC-5105.1.9Study Reports – Safety5.4XML607BlockedPriya Sharma
CC-6103.6.4Drug Product7.8HTML1,153CompletedPriya Sharma
CC-7101.8.8Patient Labeling3.7PDF9,942ApprovedPriya Sharma
CC-8103.1.3Container Closure System12.5PDF11,563OverdueMarcus Webb
CC-9105.5.8Study Reports – Safety12.8PDF10,315SubmittedCarlos Mendez
CC-10105.3.2Study Reports – Safety8.0XML7,226In ProgressLieselotte van der Berg
CC-11103.6.3Drug Substance5.4Word2,669FailedJames O'Brien
CC-12104.1.5Carcinogenicity1.7PDF13,247OverdueNadia Petrova
CC-13105.4.8Study Reports – Clinical Pharmacology12.9XML7,338DraftMarcus Webb
CC-14105.6.7Study Reports – Clinical Pharmacology11.1PDF14,714OverdueTomoko Ikeda
CC-15103.9.3Stability Data6.0PDF3,812ApprovedLieselotte van der Berg
CC-16105.5.5Study Reports – Clinical Pharmacology5.0Word11,959PendingAisha Okonkwo
CC-17102.3.9Clinical Overview11.1PDF4,880FailedTomoko Ikeda
CC-18103.2.5Manufacturing Process7.8XML14,352FailedMarcus Webb
CC-19104.6.7Genotoxicity6.1XML5,509FailedDmitri Volkov