Information request: extractables and leachables data

Correspondence from Health Sciences Authority regarding HSA-2023-0032. Type: deficiency. Risk: low. Category: Nonclinical.

Correspondence ID
COR-132
Type
deficiency
Application
HSA-2023-0032
Authority
Health Sciences Authority
Category
Nonclinical
Risk
Low
Due Date
2025-04-09
Status
Open
Owner
Aisha Okonkwo
Created
2023-02-28
Correspondence Body
Dear HSA Review Team, With reference to application HSA-2023-0032, we wish to address the following: [Detailed response body regarding deficiency letter: missing stability data for 40°c condition] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-09 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.