Information request: manufacturing process change justificat
Correspondence from Medicines and Healthcare products Regulatory Agency regarding MHRA-2022-0048. Type: deficiency. Risk: medium. Category: Clinical.
Correspondence ID
COR-048
Type
deficiency
Application
Authority
Medicines and Healthcare products Regulatory Agency
Category
Clinical
Risk
Medium
Due Date
2025-01-11
Status
Overdue
Owner
Nadia Petrova
Created
2022-10-23
Correspondence Body
Dear MHRA Review Team,
With reference to application MHRA-2022-0048, we wish to address the following:
[Detailed response body regarding request for additional clinical data on primary endpoint]
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_48.xlsxstudy_report_48.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-11 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.