Information request: extractables and leachables data

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

Correspondence ID
COR-183
Type
information-request
Application
PMDA-2022-0083
Authority
Pharmaceuticals and Medical Devices Agency
Category
Labeling
Risk
Low
Due Date
2025-03-21
Status
In Progress
Owner
Tomoko Ikeda
Created
2023-01-31
Correspondence Body
Dear PMDA Review Team, With reference to application PMDA-2022-0083, 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
study_report_183.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-21 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.