Query regarding bioequivalence study design
Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0050. Type: information-request. Risk: medium. Category: Administrative.
Correspondence ID
COR-550
Type
information-request
Application
Authority
Ministry of Food and Drug Safety
Category
Administrative
Risk
Medium
Due Date
2025-03-05
Status
In Progress
Owner
Marcus Webb
Created
2023-07-07
Correspondence Body
Dear MFDS Review Team,
With reference to application MFDS-2020-0050, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_550_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-05 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.