Query regarding bioequivalence study design
Correspondence from COFEPRIS regarding COFEPRIS-2021-0034. Type: question. Risk: low. Category: Nonclinical.
Correspondence ID
COR-234
Type
question
Application
Authority
COFEPRIS
Category
Nonclinical
Risk
Low
Due Date
2025-03-21
Status
Draft
Owner
Priya Sharma
Created
2022-10-20
Correspondence Body
Dear COFEPRIS Review Team,
With reference to application COFEPRIS-2021-0034, we wish to address the following:
[Detailed response body regarding information request: extractables and leachables data]
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: 2025-03-21 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.