Query regarding bioequivalence study design

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

Correspondence ID
COR-528
Type
query
Application
MHRA-2022-0028
Authority
Medicines and Healthcare products Regulatory Agency
Category
Nonclinical
Risk
Medium
Due Date
2025-02-16
Status
In Progress
Owner
Aisha Okonkwo
Created
2023-04-28
Correspondence Body
Dear MHRA Review Team, With reference to application MHRA-2022-0028, we wish to address the following: [Detailed response body regarding query: container closure integrity study methodology] 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: 2025-02-16 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.