Information request: extractables and leachables data

Correspondence from Food and Drug Administration regarding FDA-2024-0081. Type: question. Risk: low. Category: Labeling.

Correspondence ID
COR-281
Type
question
Application
FDA-2024-0081
Authority
Food and Drug Administration
Category
Labeling
Risk
Low
Due Date
2025-04-05
Status
Draft
Owner
Dmitri Volkov
Created
2023-05-05
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0081, 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-05 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.