Information request: manufacturing process change justificat
Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0043. Type: commitment-request. Risk: low. Category: Quality.
Correspondence ID
COR-243
Type
commitment-request
Application
Authority
Pharmaceuticals and Medical Devices Agency
Category
Quality
Risk
Low
Due Date
2025-03-12
Status
In Progress
Owner
Sarah Chen
Created
2023-09-11
Correspondence Body
Dear PMDA Review Team,
With reference to application PMDA-2022-0043, 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
study_report_243.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.