Request for post-marketing commitment progress update
Correspondence from COFEPRIS regarding COFEPRIS-2021-0054. Type: information-request. Risk: high. Category: Administrative.
Correspondence ID
COR-054
Type
information-request
Application
Authority
COFEPRIS
Category
Administrative
Risk
High
Due Date
2024-12-31
Status
Open
Owner
Marcus Webb
Created
2023-12-19
Correspondence Body
Dear COFEPRIS Review Team,
With reference to application COFEPRIS-2021-0054, we wish to address the following:
[Detailed response body regarding query: container closure integrity study methodology]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-31 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.