Query: container closure integrity study methodology
Correspondence from European Medicines Agency regarding EMA-2023-0062. Type: commitment-request. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-462
Type
commitment-request
Application
Authority
European Medicines Agency
Category
Nonclinical
Risk
Medium
Due Date
2025-02-25
Status
Overdue
Owner
Sarah Chen
Created
2023-05-05
Correspondence Body
Dear EMA Review Team,
With reference to application EMA-2023-0062, we wish to address the following:
[Detailed response body regarding query regarding bioequivalence study design]
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: 2025-02-25 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.