Tag Archives: Guidance

New FinCEN Guidance on Virtual Currency

On May 9, 2019, FinCEN, the U.S. federal agency charged with combating money laundering, issued two new interpretive documents of interest to the crypto community. The first is interpretive guidance titled “Application of FinCEN’s Regulations to Certain Business Models Involving … Continue reading

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Brave New Real World: FDA Draft Guidance Takes First Steps to Move RWE from Dystopia

By Larry J. Bauer, Senior Regulatory Drug Expert & James E. Valentine — On May 8, 2019, the FDA published a new draft guidance for industry titled “Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and … Continue reading

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CMS Releases Draft Guidance for Hospitals on Shared Space and Contracted Services

The Centers for Medicare & Medicaid Services (CMS) released a draft guidance for state survey agencies on May 3, 2019, impacting hospitals that share space, staff, and/or services with another co-located hospital or health care entity. The draft builds on … Continue reading

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Suspicious Activity Monitoring and Reporting – FINRA Issues Notice Consolidating Governmental and Regulatory “Red Flag” Guidance

Enforcement actions sanctioning firms and, in a few cases, individuals for failing to investigate and report suspicious activity have been significantly on the rise. SEC, FinCEN, FINRA, and others have been active in this area, particularly with regard to trading … Continue reading

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Take-Aways from an Advisory Opinion by the Inter-American Court of Human Rights: How Does a Human Rights Forum Give Guidance to Global Environmental Protection?

Written by: Siyi Shen, Global Environmental Law Graduate Fellow On February 8, 2018, the Inter-American Court of Human Rights (the IA Court) issued a groundbreaking advisory opinion (2018 Opinion) in response to a request by Columbia recognizing the right to … Continue reading

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