Request for post-marketing commitment progress update

Correspondence from Medicines and Healthcare products Regulatory Agency regarding MHRA-2022-0028. Type: deficiency. Risk: medium. Category: Administrative.

Correspondence ID
COR-028
Type
deficiency
Application
MHRA-2022-0028
Authority
Medicines and Healthcare products Regulatory Agency
Category
Administrative
Risk
Medium
Due Date
2025-01-09
Status
Open
Owner
Aisha Okonkwo
Created
2023-11-17
Correspondence Body
Dear MHRA Review Team, With reference to application MHRA-2022-0028, we wish to address the following: [Detailed response body regarding request for benefit-risk assessment addendum] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-09 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.