Query: container closure integrity study methodology

Correspondence from Food and Drug Administration regarding FDA-2024-0021. Type: information-request. Risk: low. Category: Clinical.

Correspondence ID
COR-121
Type
information-request
Application
FDA-2024-0021
Authority
Food and Drug Administration
Category
Clinical
Risk
Low
Due Date
2024-12-31
Status
Open
Owner
Priya Sharma
Created
2023-07-21
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0021, 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: 2024-12-31 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.