Question on comparative dissolution data
Correspondence from Health Sciences Authority regarding HSA-2023-0052. Type: deficiency. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-152
Type
deficiency
Application
Authority
Health Sciences Authority
Category
Nonclinical
Risk
Medium
Due Date
2025-04-03
Status
Open
Owner
Aisha Okonkwo
Created
2023-08-06
Correspondence Body
Dear HSA Review Team,
With reference to application HSA-2023-0052, 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
data_table_152.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-03 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.