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行业洞察美国 FDAT1057

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

·22 天前·来源:美国 FDA

🤖 AI 摘要

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act" that appeared in the Federal Register of May 1, 2026. In the Federal Register notice, FDA requested comments on FDA's proposal not to include semaglutide, tirzepatide, or liraglutide on a list of bulk drug substances (active pharmaceutical ingredie

分析模型:rule-based-v3 · 07-09 06:59

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综合分 57/100

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70

影响范围

70

时效性

50

合规紧急

40

行业关注

35

Federal Register: FDA Notices (官方通知)
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