Information request: extractables and leachables data

Correspondence from Food and Drug Administration regarding FDA-2024-0041. Type: commitment-request. Risk: high. Category: Nonclinical.

Correspondence ID
COR-541
Type
commitment-request
Application
FDA-2024-0041
Authority
Food and Drug Administration
Category
Nonclinical
Risk
High
Due Date
2024-12-17
Status
In Progress
Owner
Priya Sharma
Created
2022-09-13
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0041, we wish to address the following: [Detailed response body regarding deficiency letter: missing stability data for 40°c condition] 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: 2024-12-17 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.