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美国食品药品监督管理局(FDA)对具有致畸风险药物的分类。致畸学会公共事务委员会。

FDA classification of drugs for teratogenic risk. Teratology Society Public Affairs Committee.

出版信息

Teratology. 1994 Jun;49(6):446-7. doi: 10.1002/tera.1420490603.

DOI:10.1002/tera.1420490603
PMID:7747265
Abstract

The Teratology Society believes that the current FDA Use-in-Pregnancy Ratings should be abandoned. The Society recommends that drug labeling should include narrative statements that summarize and interpret available data regarding hazards of developmental toxicity and provide estimates of potential teratogenic risk.

摘要

畸形学协会认为,美国食品药品监督管理局(FDA)目前的孕期用药评级应予废止。该协会建议,药品标签应包含叙述性声明,总结并解释有关发育毒性危害的现有数据,并提供潜在致畸风险的评估。

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