Question on comparative dissolution data
Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0050. Type: question. Risk: medium. Category: Labeling.
Correspondence ID
COR-150
Type
question
Application
Authority
Ministry of Food and Drug Safety
Category
Labeling
Risk
Medium
Due Date
2025-02-05
Status
Open
Owner
Carlos Mendez
Created
2023-03-30
Correspondence Body
Dear MFDS Review Team,
With reference to application MFDS-2020-0050, we wish to address the following:
[Detailed response body regarding information request: manufacturing process change justification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
data_table_150.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-05 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.