Deficiency letter: missing stability data for 40°C condition
Correspondence from Medicines and Healthcare products Regulatory Agency regarding MHRA-2022-0068. Type: commitment-request. Risk: medium. Category: Clinical.
Correspondence ID
COR-368
Type
commitment-request
Application
Authority
Medicines and Healthcare products Regulatory Agency
Category
Clinical
Risk
Medium
Due Date
2025-04-12
Status
Overdue
Owner
Aisha Okonkwo
Created
2023-12-19
Correspondence Body
Dear MHRA Review Team,
With reference to application MHRA-2022-0068, we wish to address the following:
[Detailed response body regarding query regarding bioequivalence study design]
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_368.xlsxstudy_report_368.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.