Information request: manufacturing process change justificat
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0047. Type: information-request. Risk: medium. Category: Quality.
Correspondence ID
COR-247
Type
information-request
Application
Authority
Therapeutic Goods Administration
Category
Quality
Risk
Medium
Due Date
2024-12-19
Status
Open
Owner
James O'Brien
Created
2022-11-03
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_247_1.pdfdata_table_247.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-19 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.