Information request: manufacturing process change justificat
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0087. Type: deficiency. Risk: medium. Category: Labeling.
Correspondence ID
COR-487
Type
deficiency
Application
Authority
Therapeutic Goods Administration
Category
Labeling
Risk
Medium
Due Date
2025-04-30
Status
In Progress
Owner
Carlos Mendez
Created
2023-05-27
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: extractables and leachables data]
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: 2025-04-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.