Deficiency letter: missing stability data for 40°C condition

Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0063. Type: deficiency. Risk: low. Category: Nonclinical.

Correspondence ID
COR-263
Type
deficiency
Application
PMDA-2022-0063
Authority
Pharmaceuticals and Medical Devices Agency
Category
Nonclinical
Risk
Low
Due Date
2024-12-23
Status
Draft
Owner
Aisha Okonkwo
Created
2022-05-14
Correspondence Body
Dear PMDA Review Team, With reference to application PMDA-2022-0063, we wish to address the following: [Detailed response body regarding request for post-marketing commitment progress update] 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_263.xlsxstudy_report_263.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-23 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.