Query: container closure integrity study methodology

Correspondence from COFEPRIS regarding COFEPRIS-2021-0054. Type: question. Risk: low. Category: Labeling.

Correspondence ID
COR-254
Type
question
Application
COFEPRIS-2021-0054
Authority
COFEPRIS
Category
Labeling
Risk
Low
Due Date
2025-02-17
Status
In Progress
Owner
Nadia Petrova
Created
2023-12-28
Correspondence Body
Dear COFEPRIS Review Team, With reference to application COFEPRIS-2021-0054, 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
data_table_254.xlsxattachment_254_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-17 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.