Query: container closure integrity study methodology

Correspondence from Food and Drug Administration regarding FDA-2024-0001. Type: commitment-request. Risk: medium. Category: Quality.

Correspondence ID
COR-401
Type
commitment-request
Application
FDA-2024-0001
Authority
Food and Drug Administration
Category
Quality
Risk
Medium
Due Date
2025-03-24
Status
Open
Owner
Sarah Chen
Created
2024-02-18
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0001, 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
Attachments
study_report_401.pdfattachment_401_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-24 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.