All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2025-P-5933
Request that the FDA provide an explanation as to why the FDA permitted the removal of the following information from the FDA Avonex labeling information in versions SUPPL-5258 and above: Changes in MRI findings often do not correlate with changes in the clinical status of patients (e.g., disability progression)
Documents
6
Comments
0
Description
OPEN
Key Dates
Comment Period OpensNov 7, 2025
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CDER
Citizen Petition
provide an explanation as to why the FDA
permitted the removal of the following
information from the FDA Avonex labeling
information in versions SUPPL-5258 and above:
Changes in MRI findings often do not correlate
with changes in the clinical status of patients
Data from Regulations.gov