Request for additional clinical data on primary endpoint

Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0043. Type: query. Risk: low. Category: Labeling.

Correspondence ID
COR-043
Type
query
Application
PMDA-2022-0043
Authority
Pharmaceuticals and Medical Devices Agency
Category
Labeling
Risk
Low
Due Date
2024-12-21
Status
Completed
Owner
James O'Brien
Created
2022-05-29
Correspondence Body
Dear PMDA Review Team, With reference to application PMDA-2022-0043, we wish to address the following: [Detailed response body regarding gmp inspection findings clarification] 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_43.pdfdata_table_43.xlsx
Response Package
Response package assembled: RP-043