Information request: extractables and leachables data

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

Correspondence ID
COR-181
Type
question
Application
FDA-2024-0081
Authority
Food and Drug Administration
Category
Labeling
Risk
Medium
Due Date
2025-04-09
Status
Open
Owner
Sarah Chen
Created
2022-09-27
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0081, 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-09 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.