Legal Updates

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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Cryptocurrency and tax – hard forks

As many readers would be aware, investing in cryptocurrencies isn’t always limited to the traditional buy/hold/sell strategy. Cryptocurrencies are a (relatively) new and nuanced asset class, which can be applied and used in many ways that other assets cannot. There are also a number of events, such as forks, that are unique to cryptocurrencies.

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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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Employee Handbooks: Benefits, Pitfalls and Preserving At-Will Employment

Every cannabis employer should have in place an employee handbook tailored to meet the needs of its business goals and workplace culture, and to ensure compliance with all applicable state and federal laws.

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Hall & Wilcox recognises International Day of People with Disability

Today, Hall & Wilcox recognises International Day of People with Disability. The theme for this year is empowering persons with disabilities and ensuring inclusiveness and equality.

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’tis the season… for a legal hangover

Employers beware, the Christmas party is nearing and we could all be in for a legal hangover in the morning!

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Talking Tax – Issue 144

Phoenixing labour hire operator sentenced to jail in WA
In brief

A labour hire business operator who fraudulently obtained more than $890,000 through illegal phoenix activity (involving business debts, GST and PAYG obligations) has been jailed for five years and four months and ordered to repay the money.

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Proposed Rules Loosen Restrictions on Hardship Withdrawals

Based on proposed regulations released by the U.S. Department of Treasury on November 14, 2018 (the “Proposed Regulations”), participants in 401(k) and 403(b) plans may find it easier to get hardship withdrawals as early as plan years beginning after December 31, 2018. Hardship withdrawals are permitted on account of financial hardships if the distribution is made in response to an “immediate and heavy financial need” and the distribution is necessary to satisfy that need. The Proposed Regulations incorporate various prior statutory changes, including changes imposed by the 2017 Tax Act, the Bipartisan Budget Act of 2018, and the Pension Protection Act of 2006. These changes are summarized below:

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The Pursuit of “Truth” in Advertising: Data

As mentioned in my previous two posts (found here and here), I gave a presentation at the 40th Annual Association of National Advertisers/Brand Activation Association Marketing Law Conference titled “The Pursuit of ‘Truth’ in Advertising.” It explored how consumers view the truth in this era of fake news and alternative facts, and how this changing understanding of the truth has affected the advertising ecosystem and the practice of advertising law. Today, I will share the third installment in my series of highlights from my presentation.

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