Query: container closure integrity study methodology
Correspondence from ANMAT regarding ANMAT-2020-0095. Type: deficiency. Risk: low. Category: Administrative.
Correspondence ID
COR-595
Type
deficiency
Application
Authority
ANMAT
Category
Administrative
Risk
Low
Due Date
2025-01-23
Status
Overdue
Owner
James O'Brien
Created
2023-04-14
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0095, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
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: 2025-01-23 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.