Question on comparative dissolution data

Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0085. Type: query. Risk: high. Category: Labeling.

Correspondence ID
COR-285
Type
query
Application
ANVISA-2020-0085
Authority
Agência Nacional de Vigilância Sanitária
Category
Labeling
Risk
High
Due Date
2025-01-20
Status
Open
Owner
Lieselotte van der Berg
Created
2023-08-31
Correspondence Body
Dear ANVISA Review Team, With reference to application ANVISA-2020-0085, we wish to address the following: [Detailed response body regarding deficiency letter: missing stability data for 40°c condition] 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_285.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-20 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.