Query regarding bioequivalence study design
Correspondence from Swissmedic regarding SwissMedic-2021-0029. Type: deficiency. Risk: low. Category: Labeling.
Correspondence ID
COR-529
Type
deficiency
Application
Authority
Swissmedic
Category
Labeling
Risk
Low
Due Date
2024-12-12
Status
Draft
Owner
Nadia Petrova
Created
2023-03-15
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0029, we wish to address the following:
[Detailed response body regarding information request: extractables and leachables data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_529_1.pdfstudy_report_529.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.