GMP inspection findings clarification
Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0070. Type: information-request. Risk: low. Category: Nonclinical.
Correspondence ID
COR-070
Type
information-request
Application
Authority
Ministry of Food and Drug Safety
Category
Nonclinical
Risk
Low
Due Date
2025-04-02
Status
Completed
Owner
Nadia Petrova
Created
2022-11-17
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
Attachments
study_report_70.pdf
Response Package
Response package assembled: RP-070