North America

FDA Reexamining Communication Practices with Investigational New Drug Sponsors

On November 19, 2018, the FDA submitted a proposal to the White House Office of Management and Budget (OMB) to approve a review that will assess current communication practices between FDA review staff and Investigational New Drug (IND) sponsors.  The FDA has contracted with Eastern Research Group (ERG) to determine whether the current mode of communication between these parties needs to be adapted moving forward.  Depending on the results of this review, communication practices and requirements could be altered, which might have an effect on the IND application process. Possible modifications might occur that could assist in removing communication bottlenecks hindering approval timelines.

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The Supreme Court of Utah gave taxpayers a sweet victory recently in Utah State Tax Commission v. See’s Candies.

The Supreme Court of Utah gave taxpayers a sweet victory recently in Utah State Tax Commission v. See’s Candies.  In See’s Candies, the Utah State Tax Commission challenged an arrangement between two wholly owned subsidiaries of Berkshire Hathaway that provided Utah corporate franchise tax benefits. The Utah Supreme Court, however, ultimately ruled in favor of the taxpayer, See’s Candies.

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DOL Releases New Guidance on Minimum Wage for Tipped Workers – Employment Law This Week

Featured on Employment Law This Week:  The Department of Labor (“DOL”) rolls back the 80/20 rule.

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Early Christmas present for Michigan Employers: Earned Sick time Act overhauled and wage hike delayed

The Michigan legislature just gave employers an early Christmas present by scaling back on the terms of broadly-worded minimum wage and earned sick time laws that started out as citizen-initiated ballot proposals.

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New York City Sets Minimum Wage for Independent Contractors of Ride-Hailing Companies

On December 4, 2018, New York City’s Taxi and Limousine Commission (“TLC”) voted to require ride-hailing companies operating in New York City to compensate its drivers who are treated as independent contractors, and not employees, on a per-minute and –mile payment formula, which will result in a $17.22 per hour wage floor.

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FDA Reexamining Communication Practices with Investigational New Drug Sponsors

On November 19, 2018, the FDA submitted a proposal to the White House Office of Management and Budget (OMB) to approve a review that will assess current communication practices between FDA review staff and Investigational New Drug (IND) sponsors.  The FDA has contracted with Eastern Research Group (ERG) to determine whether the current mode of communication between these parties needs to be adapted moving forward.  Depending on the results of this review, communication practices and requirements could be altered, which might have an effect on the IND application process. Possible modifications might occur that could assist in removing communication bottlenecks hindering approval timelines.

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IRS Extends Deadline for Furnishing 2018 Forms 1095 to Individuals and Good Faith Transition Relief

The Internal Revenue Service (“IRS”) has released Notice 2018-94, which extends the due date for furnishing the 2018 Form 1095-B and Form 1095-C to individuals from January 31, 2019 to March 4, 2019.

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Cincinnati Reds score Ohio tax break

The Ohio Supreme Court recently issued a divided ruling in Cincinnati Reds, LLC v. Testa allowing a use tax break for the Cincinnati Reds baseball team for bobblehead dolls and other promotional items given to some attendees at their home games. Though the Court split 5-2 in the ruling, the majority opinion that Justice Patrick Fischer authored quoted longtime Reds radio announcer Marty Brennaman to hold that “[T]his one belongs to the Reds.”

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The “Yates Memo” Revisited: Pursuing Individuals Remains a DOJ Top Priority – Senior Management and Members of Boards of Directors in Focus

During a September 29, 2018 speech, Deputy Attorney General Rod Rosenstein announced changes to Department of Justice (“DOJ”) policy concerning individual accountability in corporate cases.  The announcement followed the DOJ’s year-long review of its individual accountability policies and the September 2015 memorandum issued by then-Deputy Attorney General Sally Yates, commonly known as the “Yates Memo.”

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Take 5 Newsletter – The Present-Future of Work: 2018 Trends and 2019 Predictions

There is a visceral and palpable dynamic emerging in global workplaces: tension.

Tension between what is potentially knowable—and what is actually known.   Tension between the present and the future state of work.  Tension between what was, is, and what might become (and when).  Tension between the nature, function, and limits of data and technology.

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