Query regarding bioequivalence study design
Correspondence from Swissmedic regarding SwissMedic-2021-0029. Type: question. Risk: medium. Category: Administrative.
Correspondence ID
COR-229
Type
question
Application
Authority
Swissmedic
Category
Administrative
Risk
Medium
Due Date
2025-04-12
Status
In Progress
Owner
Nadia Petrova
Created
2023-04-17
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 benefit-risk assessment addendum]
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_229.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.