Request for post-marketing commitment progress update
Correspondence from COFEPRIS regarding COFEPRIS-2021-0014. Type: deficiency. Risk: high. Category: Clinical.
Correspondence ID
COR-214
Type
deficiency
Application
Authority
COFEPRIS
Category
Clinical
Risk
High
Due Date
2025-02-06
Status
Overdue
Owner
Priya Sharma
Created
2023-10-30
Correspondence Body
Dear COFEPRIS Review Team,
With reference to application COFEPRIS-2021-0014, 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.