Information request: manufacturing process change justificat
Correspondence from Health Sciences Authority regarding HSA-2023-0092. Type: query. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-092
Type
query
Application
Authority
Health Sciences Authority
Category
Nonclinical
Risk
Medium
Due Date
2024-12-10
Status
Draft
Owner
Nadia Petrova
Created
2023-11-23
Correspondence Body
Dear HSA Review Team,
With reference to application HSA-2023-0092, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_92_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-10 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.