Question on comparative dissolution data
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0087. Type: query. Risk: high. Category: Nonclinical.
Correspondence ID
COR-387
Type
query
Application
Authority
Therapeutic Goods Administration
Category
Nonclinical
Risk
High
Due Date
2025-01-27
Status
Draft
Owner
Carlos Mendez
Created
2022-07-08
Correspondence Body
Dear TGA Review Team,
With reference to application TGA-2023-0087, 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_387.pdfattachment_387_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-27 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.