Request for post-marketing commitment progress update
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0087. Type: deficiency. Risk: medium. Category: Labeling.
Correspondence ID
COR-287
Type
deficiency
Application
Authority
Therapeutic Goods Administration
Category
Labeling
Risk
Medium
Due Date
2025-01-15
Status
Open
Owner
Aisha Okonkwo
Created
2023-08-31
Correspondence Body
Dear TGA Review Team,
With reference to application TGA-2023-0087, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
study_report_287.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-15 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.