Request for benefit-risk assessment addendum
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0007. Type: deficiency. Risk: high. Category: Labeling.
Correspondence ID
COR-307
Type
deficiency
Application
Authority
Therapeutic Goods Administration
Category
Labeling
Risk
High
Due Date
2025-03-31
Status
Draft
Owner
Aisha Okonkwo
Created
2022-09-27
Correspondence Body
Dear TGA Review Team,
With reference to application TGA-2023-0007, 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-31 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.