Query regarding bioequivalence study design
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0067. Type: information-request. Risk: medium. Category: Administrative.
Correspondence ID
COR-467
Type
information-request
Application
Authority
Therapeutic Goods Administration
Category
Administrative
Risk
Medium
Due Date
2025-03-12
Status
Draft
Owner
Nadia Petrova
Created
2024-02-13
Correspondence Body
Dear TGA Review Team,
With reference to application TGA-2023-0067, we wish to address the following:
[Detailed response body regarding query: container closure integrity study methodology]
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_467.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.