Request for additional clinical data on primary endpoint
Correspondence from Medicines and Healthcare products Regulatory Agency regarding MHRA-2022-0028. Type: query. Risk: low. Category: Nonclinical.
Correspondence ID
COR-128
Type
query
Application
Authority
Medicines and Healthcare products Regulatory Agency
Category
Nonclinical
Risk
Low
Due Date
2025-02-03
Status
Open
Owner
Marcus Webb
Created
2022-09-09
Correspondence Body
Dear MHRA Review Team,
With reference to application MHRA-2022-0028, 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_128.pdfattachment_128_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-03 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.