Information request: extractables and leachables data

Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0023. Type: commitment-request. Risk: medium. Category: Administrative.

Correspondence ID
COR-323
Type
commitment-request
Application
PMDA-2022-0023
Authority
Pharmaceuticals and Medical Devices Agency
Category
Administrative
Risk
Medium
Due Date
2024-12-24
Status
Open
Owner
Marcus Webb
Created
2022-04-19
Correspondence Body
Dear PMDA Review Team, With reference to application PMDA-2022-0023, we wish to address the following: [Detailed response body regarding request for additional clinical data on primary endpoint] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
attachment_323_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-24 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.