Deficiency letter: missing stability data for 40°C condition

Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0070. Type: query. Risk: low. Category: Labeling.

Correspondence ID
COR-270
Type
query
Application
MFDS-2020-0070
Authority
Ministry of Food and Drug Safety
Category
Labeling
Risk
Low
Due Date
2025-01-30
Status
Open
Owner
Nadia Petrova
Created
2023-12-26
Correspondence Body
Dear MFDS Review Team, With reference to application MFDS-2020-0070, we wish to address the following: [Detailed response body regarding request for post-marketing commitment progress update] 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: 2025-01-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.