Question on comparative dissolution data
Correspondence from Swissmedic regarding SwissMedic-2021-0029. Type: deficiency. Risk: medium. Category: Labeling.
Correspondence ID
COR-029
Type
deficiency
Application
Authority
Swissmedic
Category
Labeling
Risk
Medium
Due Date
2024-12-12
Status
Completed
Owner
Nadia Petrova
Created
2023-03-14
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
Response Package
Response package assembled: RP-029