Request for post-marketing commitment progress update
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0047. Type: deficiency. Risk: medium. Category: Administrative.
Correspondence ID
COR-347
Type
deficiency
Application
Authority
Therapeutic Goods Administration
Category
Administrative
Risk
Medium
Due Date
2025-01-06
Status
Draft
Owner
Priya Sharma
Created
2023-12-17
Correspondence Body
Dear TGA Review Team,
With reference to application TGA-2023-0047, we wish to address the following:
[Detailed response body regarding query regarding bioequivalence study design]
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: 2025-01-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.