Question on comparative dissolution data

Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0017. Type: deficiency. Risk: high. Category: Nonclinical.

Correspondence ID
COR-017
Type
deficiency
Application
SFDA-2023-0017
Authority
Saudi Food and Drug Authority
Category
Nonclinical
Risk
High
Due Date
2025-01-19
Status
Overdue
Owner
Lieselotte van der Berg
Created
2024-02-16
Correspondence Body
Dear SFDA Review Team, With reference to application SFDA-2023-0017, we wish to address the following: [Detailed response body regarding question on comparative dissolution data] 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_17.pdfdata_table_17.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-19 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.