General Considerations for the Use of New Approach Methodologies; Draft Guidance for Industry; Availability | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

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FDA-2025-D-6131

General Considerations for the Use of New Approach Methodologies; Draft Guidance for Industry; Availability

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Comment Period OpensMar 19, 2026

Comment Period ClosesMay 19, 2026

Type	Title	Posted	Comments	Status
Notice	General Considerations for the Use of New Approach Methodologies in Drug Development; Draft Guidance for Industry; Availability FR Doc: 2026-05390	Mar 19, 2026	--

Total Comments

CDER

FRDTS #2025-277

General Considerations for the Use of

New Approach Methodologies

Draft Guidance for Industry; Availability

Open