Request for additional clinical data on primary endpoint
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0047. Type: question. Risk: low. Category: Administrative.
Correspondence ID
COR-047
Type
question
Application
Authority
Therapeutic Goods Administration
Category
Administrative
Risk
Low
Due Date
2025-04-08
Status
In Progress
Owner
Tomoko Ikeda
Created
2023-03-11
Correspondence Body
Dear TGA Review Team,
With reference to application TGA-2023-0047, we wish to address the following:
[Detailed response body regarding information request: manufacturing process change justification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_47_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-08 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.