Query: container closure integrity study methodology
Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0070. Type: commitment-request. Risk: medium. Category: Labeling.
Correspondence ID
COR-370
Type
commitment-request
Application
Authority
Ministry of Food and Drug Safety
Category
Labeling
Risk
Medium
Due Date
2024-12-22
Status
Overdue
Owner
Priya Sharma
Created
2022-09-05
Correspondence Body
Dear MFDS Review Team,
With reference to application MFDS-2020-0070, 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: 2024-12-22 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.