Request for benefit-risk assessment addendum

Correspondence from Food and Drug Administration regarding FDA-2024-0021. Type: commitment-request. Risk: high. Category: Labeling.

Correspondence ID
COR-421
Type
commitment-request
Application
FDA-2024-0021
Authority
Food and Drug Administration
Category
Labeling
Risk
High
Due Date
2025-01-08
Status
Draft
Owner
Marcus Webb
Created
2023-01-26
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0021, 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_421.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-08 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.