Archive for November, 2021


Senate Judiciary Committee Advances False Claims Act Amendment to Full Senate

On October 28, a majority of members on the Senate Judiciary Committee voted 15-7 to advance to the full Senate a bipartisan bill that would make a number of amendments to the False Claims Act (“FCA”), including one that would make significant changes to the FCA’s definition of “materiality.” Senator…

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FDA Issues Guiding Principles for Good Machine Learning Practice for Medical Device Development

On October 27, 2021, the U.S. Food and Drug Administration (FDA), Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a set of ten guiding principles meant to aid the development of Good Machine Learning Practice (GMLP). Artificial intelligence and machine learning (AI/ML) offers the…

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Propsci Perspectives: A Goodwin Video Series

The Goodwin Propsci team has partnered with several of our clients for a short video series that explores what’s happening in the real estate life sciences industry. Goodwin’s Nicole Riley is joined by Doug Cuff, Vice President of UK Real Estate for IQHQ, a development company focusing on acquiring, developing and operating life sciences properties…

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