Query regarding bioequivalence study design
Correspondence from Medicines and Healthcare products Regulatory Agency regarding MHRA-2022-0048. Type: question. Risk: high. Category: Nonclinical.
Correspondence ID
COR-548
Type
question
Application
Authority
Medicines and Healthcare products Regulatory Agency
Category
Nonclinical
Risk
High
Due Date
2024-12-17
Status
In Progress
Owner
Dmitri Volkov
Created
2024-01-31
Correspondence Body
Dear MHRA Review Team,
With reference to application MHRA-2022-0048, 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
Attachments
data_table_548.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-17 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.