Request for benefit-risk assessment addendum
Correspondence from COFEPRIS regarding COFEPRIS-2021-0034. Type: information-request. Risk: low. Category: Nonclinical.
Correspondence ID
COR-134
Type
information-request
Application
Authority
COFEPRIS
Category
Nonclinical
Risk
Low
Due Date
2025-03-24
Status
Draft
Owner
Sarah Chen
Created
2023-05-02
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
Attachments
attachment_134_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-24 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.