Question on comparative dissolution data
Correspondence from COFEPRIS regarding COFEPRIS-2021-0094. Type: query. Risk: medium. Category: Labeling.
Correspondence ID
COR-294
Type
query
Application
Authority
COFEPRIS
Category
Labeling
Risk
Medium
Due Date
2025-03-31
Status
Draft
Owner
Marcus Webb
Created
2023-08-13
Correspondence Body
Dear COFEPRIS Review Team,
With reference to application COFEPRIS-2021-0094, we wish to address the following:
[Detailed response body regarding question on comparative dissolution 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_294.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-31 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.