Information request: manufacturing process change justificat
Correspondence from Swissmedic regarding SwissMedic-2021-0049. Type: commitment-request. Risk: low. Category: Labeling.
Correspondence ID
COR-149
Type
commitment-request
Application
Authority
Swissmedic
Category
Labeling
Risk
Low
Due Date
2025-01-08
Status
Overdue
Owner
Priya Sharma
Created
2022-06-18
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
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-08 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.