Question on comparative dissolution data
Correspondence from ANMAT regarding ANMAT-2020-0055. Type: query. Risk: low. Category: Nonclinical.
Correspondence ID
COR-055
Type
query
Application
Authority
ANMAT
Category
Nonclinical
Risk
Low
Due Date
2024-12-27
Status
In Progress
Owner
Aisha Okonkwo
Created
2023-05-04
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0055, 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
data_table_55.xlsxstudy_report_55.pdf
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.