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精选法规与标准美国 FDAT1077

FDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics

·2 个月前·来源:美国 FDA

🤖 AI 摘要

The U.S. Food and Drug Administration today issued a final guidance for industry, Postapproval Pregnancy Safety Studies, with recommendations on different methodologies that can be used in the postapproval setting to study the safety of drugs and biological products when used during pregnancy.

分析模型:rule-based-v3 · 07-09 06:59

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综合分 77/100

信源权威

95

影响范围

75

时效性

30

合规紧急

75

行业关注

75

FDA Press Releases (新闻发布)
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