Information request: extractables and leachables data

Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0051. Type: commitment-request. Risk: high. Category: Clinical.

Correspondence ID
COR-351
Type
commitment-request
Application
TFDA-2024-0051
Authority
Taiwan Food and Drug Administration
Category
Clinical
Risk
High
Due Date
2024-12-09
Status
Open
Owner
Carlos Mendez
Created
2022-06-01
Correspondence Body
Dear TFDA Review Team, With reference to application TFDA-2024-0051, we wish to address the following: [Detailed response body regarding information request: extractables and leachables data] 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_351.pdfdata_table_351.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-09 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.