Nonrulemaking

General Considerations for the Use of New Approach Methodologies; Draft Guidance for Industry; Availability

🏛 Food and Drug Administration (FDA)FDA-2025-D-6131

Pharmaceutical Policy

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1

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125

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Open

Last activity

Jun 18, 2026

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Rules, notices, and supporting material — the primary rule pinned first.

📄 Primary document

OtherMar 19, 2026

General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance

Closed on May 19, 2026💬 125 comments