The U.S. Food and Drug Administration (FDA) is continuing its effort to provide industries with updated guidance for digital health technologies. On April 3, 2023, the FDA released draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions,” requesting comments from stakeholders within 90 days of publication. This draft guidance follows a final guidance issued March 30, 2023, addressing the Section 3305 of the Consolidated Appropriations Act, 2023 amendment...

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The 10th EU-US Energy Council took place in Brussels this week. The Energy Council is an annual summit where the EU and US coordinate their stances on issues related to energy policy such as cooperation on energy security, the shift to cleaner forms of energy and cooperation on meeting the Paris Agreement targets. This was the first Council since Russia’s invasion on Ukraine, and thus, of particular importance. Established in 2009, the EU-US Energy Council is the lead transatlantic coordination forum...

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Leaner inventory has been a key topic across several consumer-facing industries—including automotive, retail, consumer products, and others—with companies paring back excess stock in the face of lower sales or gloomy forecasts. These reductions help operators instill a sense of balance amid turbulent conditions, boost productivity, and improve cash flow. At the same time, discounting to dispose of excess inventory can take a bite out of gross margins. Why the big focus on inventory? Consumer activity has remained strong in recent quarters, but...

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When a foreign entity wishes to enter the U.S. market, a major factor they may need to consider involves hiring U.S. employees.  This may seem like a daunting and overwhelming prospect, and in an effort to ‘simplify’ the matter and ‘reduce costs,’ some foreign entities may decide to payroll themselves directly (i.e., using the foreign entity as the employer) or contract with and use a professional employer organization (a “PEO).  In fact, some global PEOs are marketing heavily and...

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Recent evidence suggests that progress towards gender parity has slowed and that the gender gap has in fact widened since the pandemic. This article highlights some key legal developments in the UK and Europe that are intended to support women in the workplace—from menstrual leave in Spain to increased redundancy protections for pregnant employees in the UK. We also consider what employers can do now to keep progress on the agenda. Where are we with gender parity? Unfortunately, there is evidence...

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On April 3, 2023, the U.S. Tax Court ruled in Farhy v. Commissioner that the IRS lacks statutory authority to assess Form 5471 penalties under I.R.C. § 6038(b)(1) or (2). As a result, the IRS cannot proceed with the collection of the penalties against the taxpayer. In recent years, the IRS has aggressively enforced foreign information return penalties, including the penalty for failing to file timely and complete Forms 5471. Farhy may have significant implications for taxpayers who have...

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EIB President Werner Hoyer will lead a delegation to Washington DC between April 10-16 to join policymakers and fellow Multilateral Development Banks in forging responses to global challenges Stronger international partnership on climate action, investment in green tech and support for Ukraine will top the EIB agenda in Washington in a series of meetings on the margins of IMF/WBG events. An EIB delegation led by President Werner Hoyer, as well as Vice-Presidents Ambroise Fayolle, Teresa Czerwińska, Ricardo Mourinho and  Thomas Östros will meet...

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