Query: container closure integrity study methodology

Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0091. Type: query. Risk: low. Category: Nonclinical.

Correspondence ID
COR-391
Type
query
Application
TFDA-2024-0091
Authority
Taiwan Food and Drug Administration
Category
Nonclinical
Risk
Low
Due Date
2025-01-07
Status
In Progress
Owner
James O'Brien
Created
2022-10-26
Correspondence Body
Dear TFDA Review Team, With reference to application TFDA-2024-0091, 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_391.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-07 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.