Request for additional clinical data on primary endpoint

Correspondence from Medicines and Healthcare products Regulatory Agency regarding MHRA-2022-0068. Type: deficiency. Risk: medium. Category: Nonclinical.

Correspondence ID
COR-468
Type
deficiency
Application
MHRA-2022-0068
Authority
Medicines and Healthcare products Regulatory Agency
Category
Nonclinical
Risk
Medium
Due Date
2025-04-11
Status
Open
Owner
James O'Brien
Created
2022-10-30
Correspondence Body
Dear MHRA Review Team, With reference to application MHRA-2022-0068, 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
data_table_468.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-11 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.