Requests that the FDA Formally recognize and require regulatory distinction between “active” and “non-active” primary progressive multiple sclerosis in Drug approval decisions, Indications, Clinical trial design expectations, and Prescribing information and labeling. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-0774

Requests that the FDA Formally recognize and require regulatory distinction between “active” and “non-active” primary progressive multiple sclerosis in Drug approval decisions, Indications, Clinical trial design expectations, and Prescribing information and labeling.

Documents

Comments

Key Dates

Comment Period OpensJan 27, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Interim Response to Kaylin Bower	Jul 22, 2026	--

Keywords

CDER

Citizen Petition

Formally recognize and require regulatory

distinction between active and non-active

primary progressive multiple sclerosis

Drug approval decisions

Indications

Clinical trial design expectations and

Data from Regulations.gov