Request for post-marketing commitment progress update
Correspondence from Swissmedic regarding SwissMedic-2021-0009. Type: deficiency. Risk: low. Category: Nonclinical.
Correspondence ID
COR-409
Type
deficiency
Application
Authority
Swissmedic
Category
Nonclinical
Risk
Low
Due Date
2024-12-30
Status
In Progress
Owner
Priya Sharma
Created
2023-09-09
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0009, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
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_409.xlsxstudy_report_409.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.