Deficiency letter: missing stability data for 40°C condition

Correspondence from Therapeutic Goods Administration regarding TGA-2023-0027. Type: query. Risk: medium. Category: Administrative.

Correspondence ID
COR-127
Type
query
Application
TGA-2023-0027
Authority
Therapeutic Goods Administration
Category
Administrative
Risk
Medium
Due Date
2024-12-14
Status
In Progress
Owner
Sarah Chen
Created
2023-01-21
Correspondence Body
Dear TGA Review Team, With reference to application TGA-2023-0027, we wish to address the following: [Detailed response body regarding question on comparative dissolution data] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
attachment_127_1.pdfdata_table_127.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-14 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.