Query regarding bioequivalence study design
Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0003. Type: question. Risk: low. Category: Labeling.
Correspondence ID
COR-403
Type
question
Application
Authority
Pharmaceuticals and Medical Devices Agency
Category
Labeling
Risk
Low
Due Date
2025-03-23
Status
In Progress
Owner
Tomoko Ikeda
Created
2023-11-07
Correspondence Body
Dear PMDA Review Team,
With reference to application PMDA-2022-0003, we wish to address the following:
[Detailed response body regarding information request: manufacturing process change 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_403_1.pdfstudy_report_403.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-23 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.