Request that the FDA provide an explanation as to why the FDA permitted the removal of the following information from the FDA Tysabri labeling information in versions SUPPL-840 and above: Changes in MRI findings often do not correlate with changes in the clinical status of patients (e.g., disability progression). | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-P-5852

Request that the FDA provide an explanation as to why the FDA permitted the removal of the following information from the FDA Tysabri labeling information in versions SUPPL-840 and above: Changes in MRI findings often do not correlate with changes in the clinical status of patients (e.g., disability progression).

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensNov 5, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Interim Response Letter from FDA CDER to Kaylin Bower	Apr 27, 2026	--

Keywords

CDER

Citizen Petition

provide an explanation as to why

the FDA permitted the removal of the

following information from the FDA

Tysabri labeling information in versions

SUPPL-840 and above: Changes in MRI findings

often do not correlate with changes in the

Data from Regulations.gov