Query regarding bioequivalence study design

Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0057. Type: commitment-request. Risk: low. Category: Nonclinical.

Correspondence ID
COR-457
Type
commitment-request
Application
SFDA-2023-0057
Authority
Saudi Food and Drug Authority
Category
Nonclinical
Risk
Low
Due Date
2025-04-04
Status
Overdue
Owner
Dmitri Volkov
Created
2023-09-28
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
study_report_457.pdfdata_table_457.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-04 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.