Deficiency letter: missing stability data for 40°C condition

Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0080. Type: commitment-request. Risk: medium. Category: Quality.

Correspondence ID
COR-080
Type
commitment-request
Application
MOH-IL-2020-0080
Authority
Israel Ministry of Health
Category
Quality
Risk
Medium
Due Date
2025-02-26
Status
Completed
Owner
Marcus Webb
Created
2023-08-05
Correspondence Body
Dear MOH-IL Review Team, With reference to application MOH-IL-2020-0080, 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_80.xlsxattachment_80_1.pdf
Response Package
Response package assembled: RP-080