Information request: manufacturing process change justificat

Correspondence from Food and Drug Administration regarding FDA-2024-0061. Type: query. Risk: high. Category: Administrative.

Correspondence ID
COR-561
Type
query
Application
FDA-2024-0061
Authority
Food and Drug Administration
Category
Administrative
Risk
High
Due Date
2024-12-03
Status
Open
Owner
James O'Brien
Created
2023-07-23
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0061, 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
Attachments
study_report_561.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-03 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.