Question on comparative dissolution data
Correspondence from Swissmedic regarding SwissMedic-2021-0049. Type: query. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-049
Type
query
Application
Authority
Swissmedic
Category
Nonclinical
Risk
Medium
Due Date
2025-03-10
Status
Open
Owner
Lieselotte van der Berg
Created
2022-05-13
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0049, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
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_49.pdfdata_table_49.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-10 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.