Information request: extractables and leachables data
Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0071. Type: question. Risk: medium. Category: Quality.
Correspondence ID
COR-171
Type
question
Application
Authority
Taiwan Food and Drug Administration
Category
Quality
Risk
Medium
Due Date
2025-03-04
Status
Overdue
Owner
Tomoko Ikeda
Created
2024-03-07
Correspondence Body
Dear TFDA Review Team,
With reference to application TFDA-2024-0071, we wish to address the following:
[Detailed response body regarding request for benefit-risk assessment addendum]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
data_table_171.xlsxattachment_171_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-04 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.