Request for benefit-risk assessment addendum

Correspondence from Medicines and Healthcare products Regulatory Agency regarding MHRA-2022-0008. Type: information-request. Risk: high. Category: Administrative.

Correspondence ID
COR-208
Type
information-request
Application
MHRA-2022-0008
Authority
Medicines and Healthcare products Regulatory Agency
Category
Administrative
Risk
High
Due Date
2025-01-14
Status
In Progress
Owner
Carlos Mendez
Created
2022-11-28
Correspondence Body
Dear MHRA Review Team, With reference to application MHRA-2022-0008, we wish to address the following: [Detailed response body regarding request for post-marketing commitment progress update] 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: 2025-01-14 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.