Question on comparative dissolution data

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

Correspondence ID
COR-223
Type
commitment-request
Application
PMDA-2022-0023
Authority
Pharmaceuticals and Medical Devices Agency
Category
Nonclinical
Risk
Medium
Due Date
2025-03-05
Status
Open
Owner
Sarah Chen
Created
2022-10-06
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 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_223.xlsxattachment_223_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-05 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.