Deficiency letter: missing stability data for 40°C condition
Correspondence from European Medicines Agency regarding EMA-2023-0022. Type: question. Risk: high. Category: Nonclinical.
Correspondence ID
COR-422
Type
question
Application
Authority
European Medicines Agency
Category
Nonclinical
Risk
High
Due Date
2025-04-11
Status
Open
Owner
Carlos Mendez
Created
2023-01-12
Correspondence Body
Dear EMA Review Team,
With reference to application EMA-2023-0022, we wish to address the following:
[Detailed response body regarding query: container closure integrity study methodology]
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_422.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-11 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.