Information request: manufacturing process change justificat

Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0083. Type: information-request. Risk: high. Category: Administrative.

Correspondence ID
COR-383
Type
information-request
Application
PMDA-2022-0083
Authority
Pharmaceuticals and Medical Devices Agency
Category
Administrative
Risk
High
Due Date
2025-03-11
Status
In Progress
Owner
Aisha Okonkwo
Created
2022-12-20
Correspondence Body
Dear PMDA Review Team, With reference to application PMDA-2022-0083, 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: 2025-03-11 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.