Deficiency letter: missing stability data for 40°C condition

Correspondence from Food and Drug Administration regarding FDA-2024-0001. Type: deficiency. Risk: high. Category: Clinical.

Correspondence ID
COR-501
Type
deficiency
Application
FDA-2024-0001
Authority
Food and Drug Administration
Category
Clinical
Risk
High
Due Date
2024-12-23
Status
In Progress
Owner
Nadia Petrova
Created
2022-12-31
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0001, 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: 2024-12-23 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.