GMP inspection findings clarification
Correspondence from European Medicines Agency regarding EMA-2023-0042. Type: information-request. Risk: low. Category: Clinical.
Correspondence ID
COR-242
Type
information-request
Application
Authority
European Medicines Agency
Category
Clinical
Risk
Low
Due Date
2025-04-22
Status
Draft
Owner
Lieselotte van der Berg
Created
2024-02-09
Correspondence Body
Dear EMA Review Team,
With reference to application EMA-2023-0042, we wish to address the following:
[Detailed response body regarding request for additional clinical data on primary endpoint]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-22 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.