Information request: manufacturing process change justificat
Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0091. Type: question. Risk: medium. Category: Clinical.
Correspondence ID
COR-091
Type
question
Application
Authority
Taiwan Food and Drug Administration
Category
Clinical
Risk
Medium
Due Date
2024-12-15
Status
Open
Owner
James O'Brien
Created
2023-07-11
Correspondence Body
Dear TFDA Review Team,
With reference to application TFDA-2024-0091, we wish to address the following:
[Detailed response body regarding query regarding bioequivalence study design]
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_91.xlsxattachment_91_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-15 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.