Information request: extractables and leachables data

Correspondence from Therapeutic Goods Administration regarding TGA-2023-0027. Type: deficiency. Risk: medium. Category: Administrative.

Correspondence ID
COR-427
Type
deficiency
Application
TGA-2023-0027
Authority
Therapeutic Goods Administration
Category
Administrative
Risk
Medium
Due Date
2025-04-03
Status
In Progress
Owner
Tomoko Ikeda
Created
2023-06-15
Correspondence Body
Dear TGA Review Team, With reference to application TGA-2023-0027, we wish to address the following: [Detailed response body regarding question on comparative dissolution data] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
attachment_427_1.pdfdata_table_427.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-03 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.