Request for additional clinical data on primary endpoint
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0067. Type: question. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-067
Type
question
Application
Authority
Therapeutic Goods Administration
Category
Nonclinical
Risk
Medium
Due Date
2025-01-23
Status
Draft
Owner
Nadia Petrova
Created
2023-12-09
Correspondence Body
Dear TGA Review Team,
With reference to application TGA-2023-0067, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
study_report_67.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-23 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.