Request for post-marketing commitment progress update
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0087. Type: question. Risk: medium. Category: Labeling.
Correspondence ID
COR-087
Type
question
Application
Authority
Therapeutic Goods Administration
Category
Labeling
Risk
Medium
Due Date
2025-04-14
Status
Draft
Owner
Priya Sharma
Created
2022-08-26
Correspondence Body
Dear TGA Review Team,
With reference to application TGA-2023-0087, 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: 2025-04-14 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.