Query regarding bioequivalence study design
Correspondence from COFEPRIS regarding COFEPRIS-2021-0094. Type: question. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-494
Type
question
Application
Authority
COFEPRIS
Category
Nonclinical
Risk
Medium
Due Date
2025-03-06
Status
Draft
Owner
Nadia Petrova
Created
2023-03-05
Correspondence Body
Dear COFEPRIS Review Team,
With reference to application COFEPRIS-2021-0094, we wish to address the following:
[Detailed response body regarding information request: manufacturing process change justification]
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_494.xlsxstudy_report_494.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.