Query: container closure integrity study methodology

Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0063. Type: query. Risk: low. Category: Clinical.

Correspondence ID
COR-563
Type
query
Application
PMDA-2022-0063
Authority
Pharmaceuticals and Medical Devices Agency
Category
Clinical
Risk
Low
Due Date
2025-03-23
Status
Overdue
Owner
Dmitri Volkov
Created
2022-10-12
Correspondence Body
Dear PMDA Review Team, With reference to application PMDA-2022-0063, we wish to address the following: [Detailed response body regarding information request: manufacturing process change justification] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
data_table_563.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-23 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.