Query regarding bioequivalence study design
Correspondence from Swissmedic regarding SwissMedic-2021-0009. Type: question. Risk: medium. Category: Administrative.
Correspondence ID
COR-009
Type
question
Application
Authority
Swissmedic
Category
Administrative
Risk
Medium
Due Date
2025-01-03
Status
Open
Owner
Tomoko Ikeda
Created
2022-04-19
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0009, we wish to address the following:
[Detailed response body regarding information request: manufacturing process change justification]
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: 2025-01-03 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.