GMP inspection findings clarification
Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0083. Type: deficiency. Risk: medium. Category: Labeling.
Correspondence ID
COR-583
Type
deficiency
Application
Authority
Pharmaceuticals and Medical Devices Agency
Category
Labeling
Risk
Medium
Due Date
2025-01-16
Status
In Progress
Owner
Nadia Petrova
Created
2023-08-18
Correspondence Body
Dear PMDA Review Team,
With reference to application PMDA-2022-0083, we wish to address the following:
[Detailed response body regarding request for benefit-risk assessment addendum]
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: 2025-01-16 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.