Request for benefit-risk assessment addendum
Correspondence from ANMAT regarding ANMAT-2020-0035. Type: query. Risk: high. Category: Quality.
Correspondence ID
COR-135
Type
query
Application
Authority
ANMAT
Category
Quality
Risk
High
Due Date
2025-01-17
Status
Draft
Owner
Marcus Webb
Created
2022-10-03
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0035, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
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_135.xlsxattachment_135_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-17 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.