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List of Bulk Drug Substances For Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Notice

🏛 Food and Drug Administration (FDA)FDA-2018-N-3240

Pharmaceutical Policy

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3

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3,901

322 awaiting analysis

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Open

Last activity

Jun 29, 2026

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Documents

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

All 3 Notice 2 Other 1

📄 Primary document

NoticeJun 26, 2026

List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period

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Other· Jun 15, 2026
Request for Extension from Collaborative for Evidence-Based Medicines→
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Notice· May 1, 2026
List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act→
Closing soon · 1 day left💬 3,901