Request for post-marketing commitment progress update
Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0057. Type: deficiency. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-557
Type
deficiency
Application
Authority
Saudi Food and Drug Authority
Category
Nonclinical
Risk
Medium
Due Date
2024-12-13
Status
Open
Owner
Marcus Webb
Created
2022-07-21
Correspondence Body
Dear SFDA Review Team,
With reference to application SFDA-2023-0057, we wish to address the following:
[Detailed response body regarding request for benefit-risk assessment addendum]
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_557.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.