Request for additional clinical data on primary endpoint

Correspondence from Therapeutic Goods Administration regarding TGA-2023-0087. Type: question. Risk: low. Category: Administrative.

Correspondence ID
COR-587
Type
question
Application
TGA-2023-0087
Authority
Therapeutic Goods Administration
Category
Administrative
Risk
Low
Due Date
2025-03-21
Status
In Progress
Owner
Lieselotte van der Berg
Created
2023-04-18
Correspondence Body
Dear TGA Review Team, With reference to application TGA-2023-0087, 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
data_table_587.xlsxstudy_report_587.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-21 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.