Request for benefit-risk assessment addendum
Correspondence from COFEPRIS regarding COFEPRIS-2021-0074. Type: question. Risk: low. Category: Clinical.
Correspondence ID
COR-474
Type
question
Application
Authority
COFEPRIS
Category
Clinical
Risk
Low
Due Date
2024-12-13
Status
Open
Owner
Lieselotte van der Berg
Created
2023-04-10
Correspondence Body
Dear COFEPRIS Review Team,
With reference to application COFEPRIS-2021-0074, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
study_report_474.pdfdata_table_474.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-13 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.