Information request: extractables and leachables data

Correspondence from Therapeutic Goods Administration regarding TGA-2023-0027. Type: commitment-request. Risk: low. Category: Nonclinical.

Correspondence ID
COR-527
Type
commitment-request
Application
TGA-2023-0027
Authority
Therapeutic Goods Administration
Category
Nonclinical
Risk
Low
Due Date
2025-01-10
Status
Overdue
Owner
Priya Sharma
Created
2023-08-31
Correspondence Body
Dear TGA Review Team, With reference to application TGA-2023-0027, 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
Attachments
study_report_527.pdfdata_table_527.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-10 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.