General Considerations for the Use of New Approach Methodologies; Draft Guidance for Industry; Availability | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-D-6131

General Considerations for the Use of New Approach Methodologies; Draft Guidance for Industry; Availability

Documents

Comments

125

Description

Open

Comment Period OpensMar 19, 2026

Comment Period ClosesMay 19, 2026

Type	Title	Posted	Comments	Status
Other	General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance	Mar 19, 2026	125

Total Comments

125

CDER

FRDTS #2025-277

General Considerations for the Use of

New Approach Methodologies

Draft Guidance for Industry; Availability

Open