Request for post-marketing commitment progress update
Correspondence from ANMAT regarding ANMAT-2020-0015. Type: deficiency. Risk: high. Category: Clinical.
Correspondence ID
COR-115
Type
deficiency
Application
Authority
ANMAT
Category
Clinical
Risk
High
Due Date
2024-12-23
Status
Completed
Owner
Aisha Okonkwo
Created
2023-12-23
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0015, 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
data_table_115.xlsxattachment_115_1.pdf
Response Package
Response package assembled: RP-115