Query: container closure integrity study methodology
Correspondence from Swissmedic regarding SwissMedic-2021-0049. Type: deficiency. Risk: low. Category: Quality.
Correspondence ID
COR-449
Type
deficiency
Application
Authority
Swissmedic
Category
Quality
Risk
Low
Due Date
2025-01-13
Status
Overdue
Owner
Marcus Webb
Created
2022-07-20
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0049, we wish to address the following:
[Detailed response body regarding request for additional clinical data on primary endpoint]
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_449.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-13 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.