Request for post-marketing commitment progress update

Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0063. Type: deficiency. Risk: medium. Category: Administrative.

Correspondence ID
COR-163
Type
deficiency
Application
PMDA-2022-0063
Authority
Pharmaceuticals and Medical Devices Agency
Category
Administrative
Risk
Medium
Due Date
2024-12-30
Status
Overdue
Owner
Tomoko Ikeda
Created
2023-10-31
Correspondence Body
Dear PMDA Review Team, With reference to application PMDA-2022-0063, 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
Attachments
study_report_163.pdfdata_table_163.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.