Query regarding bioequivalence study design
Correspondence from Swissmedic regarding SwissMedic-2021-0009. Type: query. Risk: low. Category: Quality.
Correspondence ID
COR-109
Type
query
Application
Authority
Swissmedic
Category
Quality
Risk
Low
Due Date
2025-04-28
Status
Draft
Owner
Aisha Okonkwo
Created
2023-11-09
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0009, we wish to address the following:
[Detailed response body regarding request for post-marketing commitment progress update]
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_109.xlsxstudy_report_109.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-28 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.