Information request: manufacturing process change justificat
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0047. Type: commitment-request. Risk: low. Category: Clinical.
Correspondence ID
COR-547
Type
commitment-request
Application
Authority
Therapeutic Goods Administration
Category
Clinical
Risk
Low
Due Date
2025-02-03
Status
In Progress
Owner
Nadia Petrova
Created
2023-10-31
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: 2025-02-03 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.