For the first time, the FDA had approved the clinical trial of an investigational therapy based solely on preclinical efficacy data obtained in human OoC studies

Release time:

2022-08-01 00:00

Source:

FDA首次完全基于在人类器官芯片研究中获得的临床前疗效数据，批准一款在研疗法进入临床试验

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U.S. President Biden signed into law the FDA Modernization Act 2.0, eliminating federal mandatory requirement for animal testing for new and generic drugs

The U.S. House of Representatives passed the Food and Drug Amendments of 2022, which includes OoCs and Microphysiological Systems (MPSs) as independent systems for evaluating drugs in non-clinical trials

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Previous Page

U.S. President Biden signed into law the FDA Modernization Act 2.0, eliminating federal mandatory requirement for animal testing for new and generic drugs

Next Page

The U.S. House of Representatives passed the Food and Drug Amendments of 2022, which includes OoCs and Microphysiological Systems (MPSs) as independent systems for evaluating drugs in non-clinical trials

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