Question on comparative dissolution data

Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0097. Type: information-request. Risk: low. Category: Administrative.

Correspondence ID
COR-397
Type
information-request
Application
SFDA-2023-0097
Authority
Saudi Food and Drug Authority
Category
Administrative
Risk
Low
Due Date
2025-02-25
Status
In Progress
Owner
Aisha Okonkwo
Created
2023-01-30
Correspondence Body
Dear SFDA Review Team, With reference to application SFDA-2023-0097, we wish to address the following: [Detailed response body regarding information request: manufacturing process change justification] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
attachment_397_1.pdfstudy_report_397.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-25 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.