Request for benefit-risk assessment addendum

Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0077. Type: deficiency. Risk: high. Category: Administrative.

Correspondence ID
COR-477
Type
deficiency
Application
SFDA-2023-0077
Authority
Saudi Food and Drug Authority
Category
Administrative
Risk
High
Due Date
2025-01-09
Status
Overdue
Owner
Marcus Webb
Created
2022-11-05
Correspondence Body
Dear SFDA Review Team, With reference to application SFDA-2023-0077, 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_477.xlsxstudy_report_477.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-09 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.