Request for benefit-risk assessment addendum
Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0010. Type: information-request. Risk: high. Category: Quality.
Correspondence ID
COR-110
Type
information-request
Application
Authority
Ministry of Food and Drug Safety
Category
Quality
Risk
High
Due Date
2024-12-27
Status
Draft
Owner
Nadia Petrova
Created
2022-05-11
Correspondence Body
Dear MFDS Review Team,
With reference to application MFDS-2020-0010, we wish to address the following:
[Detailed response body regarding information request: extractables and leachables data]
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_110.pdfdata_table_110.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-27 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.