Information request: extractables and leachables data
Correspondence from Swissmedic regarding SwissMedic-2021-0069. Type: commitment-request. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-469
Type
commitment-request
Application
Authority
Swissmedic
Category
Nonclinical
Risk
Medium
Due Date
2024-12-17
Status
Overdue
Owner
Lieselotte van der Berg
Created
2023-05-21
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0069, we wish to address the following:
[Detailed response body regarding deficiency letter: missing stability data for 40°c condition]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
study_report_469.pdfdata_table_469.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-17 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.