加强临床试验和生物研究监管。

FDA consumer Pub Date : 2006-11-01

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引用次数: 0

摘要

美国食品和药物管理局宣布了新的政策和监管发展，以加强该机构对临床试验患者的监督和保护，以及结果数据的完整性。人类受试者保护和生物研究监测(HSP/BIMO)计划将有助于该机构对设备、食品、人用药物、生物药物制品和兽药进行生物研究监测的方法现代化。

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Strengthening the regulation of clinical trials and bioresearch monitoring.

The Food and Drug Administration has announced new policy and regulatory developments to strengthen the agency's oversight and protection of patients in clinical trials and the integrity of resulting data. The Human Subject Protection and Bioresearch Monitoring (HSP/BIMO) initiative will help modernize the agency's approach to bioresearch monitoring of devices, foods, human drugs, biological drug products, and veterinary medicine.

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FDA consumer

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