Query regarding bioequivalence study design
Correspondence from Medicines and Healthcare products Regulatory Agency regarding MHRA-2022-0088. Type: query. Risk: high. Category: Labeling.
Correspondence ID
COR-388
Type
query
Application
Authority
Medicines and Healthcare products Regulatory Agency
Category
Labeling
Risk
High
Due Date
2025-04-30
Status
Draft
Owner
Priya Sharma
Created
2022-09-23
Correspondence Body
Dear MHRA Review Team,
With reference to application MHRA-2022-0088, 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
attachment_388_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.