Query regarding bioequivalence study design
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0067. Type: question. Risk: medium. Category: Administrative.
Correspondence ID
COR-267
Type
question
Application
Authority
Therapeutic Goods Administration
Category
Administrative
Risk
Medium
Due Date
2024-11-25
Status
Open
Owner
Marcus Webb
Created
2023-05-21
Correspondence Body
Dear TGA Review Team,
With reference to application TGA-2023-0067, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
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: 2024-11-25 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.