Deficiency letter: missing stability data for 40°C condition
Correspondence from COFEPRIS regarding COFEPRIS-2021-0034. Type: question. Risk: low. Category: Labeling.
Correspondence ID
COR-034
Type
question
Application
Authority
COFEPRIS
Category
Labeling
Risk
Low
Due Date
2025-03-14
Status
Draft
Owner
Aisha Okonkwo
Created
2022-08-07
Correspondence Body
Dear COFEPRIS Review Team,
With reference to application COFEPRIS-2021-0034, we wish to address the following:
[Detailed response body regarding request for post-marketing commitment progress update]
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_34.xlsxattachment_34_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-14 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.