Information request: manufacturing process change justificat
Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0091. Type: question. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-191
Type
question
Application
Authority
Taiwan Food and Drug Administration
Category
Nonclinical
Risk
Medium
Due Date
2024-12-06
Status
In Progress
Owner
Carlos Mendez
Created
2023-01-07
Correspondence Body
Dear TFDA Review Team,
With reference to application TFDA-2024-0091, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_191_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.