Legal Updates

New in procedure of introducing drugs into commercial turnover

On November 28, 2018 the Federal law of November 28, 2018 No. 449-FZ “On amendments being made to separate legal acts regarding introduction of drugs into commercial turnover” (the “Law”) was published on the official web portal of legal information. The main changes introduced by the Law are as follows:

Read more

Read full article

FDA to Overhaul Medical Device Approval Process

On November 26, 2018, the U.S. Food and Drug Administration (“FDA”) announced the process for clearing most medical devices for marketing is being updated to incorporate changes the FDA laid out in an April draft guidance. For over forty years, most medical devices have entered the United States market through the 510(k) clearance process. The 510(k) process offers an expedited approval process available only for products that are substantially equivalent to products already on the market (known as predicate devices). The FDA is considering no longer allowing sponsors to rely on predicates older than ten years and making public information about cleared devices that relied on predicates more than ten years old. In addition, the FDA intends to finalize guidance establishing an alternative 510(k) pathway with different criteria that reflect current technological principles.

Read more

Read full article

January reporting deadline approaching for owners and operators of critical infrastructure

If you are a responsible entity for, or direct interest holder in, a ‘critical infrastructure asset’ you have until 11 January 2019 to comply with your initial reporting obligations under the Security of Critical Infrastructure Act 2018. If you have not already done so, now is the time to start considering and collecting the information that you will need to report. This article will assist you in understanding the new reporting framework and your reporting obligations.

Read more

Read full article

Sweeping victory for RSS before the Supreme Court

December 7, 2018 — This morning, the Supreme Court of Canada released its decision in Brunette v. Legault Joly Thiffault, s.e.n.c.r.l., 2018 SCC 55, a professional liability case with stakes of $55 million. It dismissed the claim at the preliminary stage, restating two legal principles:

Read more

Read full article

Hall & Wilcox expands national insurance and litigation practice with new appointment

Leading independent business law firm Hall & Wilcox has expanded its national insurance and litigation capabilities following the appointment of Special Counsel Vicky Kossaris, who joined the firm on 3 December.

Read more

Read full article

Talking Tax – Issue 145

Time limits for claiming input tax or fuel tax credit: open for consultation

In brief

The ATO’s new Draft Miscellaneous Taxation Ruling MT 2018/D1 (Draft Ruling) outlines the Commissioner of Taxation’s (Commissioner) view on time limits applying to the entitlement to claim an input tax or fuel tax credit. The Draft Ruling is open for consultation until 25 January 2019.

Read more

Read full article

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.

Read more

Read full article

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.

Read more

Read full article

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.

Read more

Read full article

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.

Read more

Read full article