Query: container closure integrity study methodology

Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0083. Type: information-request. Risk: medium. Category: Administrative.

Correspondence ID
COR-283
Type
information-request
Application
PMDA-2022-0083
Authority
Pharmaceuticals and Medical Devices Agency
Category
Administrative
Risk
Medium
Due Date
2025-04-11
Status
In Progress
Owner
Tomoko Ikeda
Created
2023-12-05
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 updated smpc section 4.1] 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_283.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-11 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.