Request for benefit-risk assessment addendum

Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0010. Type: information-request. Risk: low. Category: Quality.

Correspondence ID
COR-010
Type
information-request
Application
MFDS-2020-0010
Authority
Ministry of Food and Drug Safety
Category
Quality
Risk
Low
Due Date
2024-12-16
Status
In Progress
Owner
Dmitri Volkov
Created
2022-05-29
Correspondence Body
Dear MFDS Review Team, With reference to application MFDS-2020-0010, 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
Attachments
attachment_10_1.pdfdata_table_10.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-16 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.