Query regarding bioequivalence study design
Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0003. Type: deficiency. Risk: low. Category: Quality.
Correspondence ID
COR-103
Type
deficiency
Application
Authority
Pharmaceuticals and Medical Devices Agency
Category
Quality
Risk
Low
Due Date
2025-01-19
Status
Overdue
Owner
Nadia Petrova
Created
2024-03-05
Correspondence Body
Dear PMDA Review Team,
With reference to application PMDA-2022-0003, we wish to address the following:
[Detailed response body regarding query: container closure integrity study methodology]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-19 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.