Question on comparative dissolution data
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0027. Type: question. Risk: medium. Category: Administrative.
Correspondence ID
COR-027
Type
question
Application
Authority
Therapeutic Goods Administration
Category
Administrative
Risk
Medium
Due Date
2024-12-22
Status
Open
Owner
Aisha Okonkwo
Created
2022-06-12
Correspondence Body
Dear TGA Review Team,
With reference to application TGA-2023-0027, 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_27.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-22 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.