Request for benefit-risk assessment addendum
Correspondence from Swissmedic regarding SwissMedic-2021-0029. Type: query. Risk: high. Category: Clinical.
Correspondence ID
COR-429
Type
query
Application
Authority
Swissmedic
Category
Clinical
Risk
High
Due Date
2025-03-29
Status
In Progress
Owner
Aisha Okonkwo
Created
2023-01-11
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0029, 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_429.xlsxstudy_report_429.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-29 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.