Monthly Archives: August 2016

FDA Announces November Public Hearing on Off-Label Communications: An Important Step Forward or a Signal that FDA is Headed Back to the Drawing Board?

On August 31, 2016, FDA issued a notification of public hearing and request for comments on manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016, and individuals wishing to present information at the hearing must register by October 19, 2016. The deadline for written comments is January 9, 2017.

In the notice, FDA posed a series of questions on which it is seeking input from a broad group of stakeholders, including manufacturers, health care providers, patient advocates, payors, academics and public interest groups. The topics on which FDA is seeking feedback are broad, but generally include:

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Governor Rick Scott Appoints Daniel O’Keefe to South Florida Water Management District

Governor Rick Scott announced the reappointment of Daniel O’Keefe, a partner in the Orlando office of Shutts & Bowen, to the South Florida Water Management District.

The South Florida Water Management District is a regional governmental agency that manages the water resources in the southern half of the state, covering 16 counties from Orlando to the Florida Keys. The agency is responsible for managing and protecting water resources of South Florida by balancing and improving flood control, water supply, water quality and natural systems.

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Second Circuit Narrows ‘Red Flag Knowledge’ Exception to DMCA’s Safe Harbor Protections for ISPs

In a long-standing case brought against the video platform Vimeo by several music publishers, the U.S. Court of Appeals for the Second Circuit recently set the bar high for copyright owners to succeed in their infringement claims against service providers based on allegations of “red flag knowledge.”

The Second Circuit, shedding some light on what is needed to establish red flag knowledge, rejected the publishers’ argument that Vimeo was not entitled to the Digital Millennium Copyright Act’s (DMCA) “safe harbor” protections for numerous videos on Vimeo’s platform that included their copyrighted music because the facts and circumstances made the infringements apparent.

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Limerick Chamber Regional Business Awards Launch

HOMS Solicitors are delighted to again support the 2016 Limerick Chamber Regional Business Awards. We are sponsoring the Best Large Business Award.

Limerick Chamber is now accepting applications from businesses of all sizes and sectors to be considered for one of the eleven award categories:-

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The Right Way to be a Lawyer of the Future

photo-1447433865958-f402f562b843A couple of weeks ago, I shared HighQ’s eBook on Smart Law, addressing the question “What do you believe lawyers and law firms need to do to prepare for the future of legal services?” My response to their question is that firms need flexibility, and today and over the next few months, I want to look at what some of the other contributors consider to be essential to the future of the legal industry.

As I’m sure we all have our own thoughts on where the industry is headed and why, don’t be shy about sharing your answers to HighQ’s question in the comments, and responding to what the other contributors had to say as well! 

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Labour Market Impact Assessments – Employers Should Expect Delays In Receiving Decisions

Recent correspondence with Employment and Social Development Canada (ESDC)/Service Canada Atlantic Region, suggests that the LMIA program has received an unexpectedly high number of applications and that its existing resources are unable to process LMIA applications in a timely manner.

Whether these delays are replicated at other ESDC offices throughout Canada remains to be seen but it would be prudent for employers and their representatives to anticipate delays and plan accordingly.

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New DHS Rule Seeks to Attract Foreign Entrepreneurs to the U.S.

On August 29, 2016, the U.S. Department of Homeland Security (DHS) issued a proposed rule which, if adopted in its present form, would ease the ability of foreign national (FN) entrepreneurs to temporarily enter the United States to invest in and grow start-up businesses.  At the present time, there is no temporary visa classification that permits FNs to make significant investments in new or growing businesses and then remain here to manage them.  In announcing this proposed rule, DHS indicated that it was intended to spur business growth and job creation at a time when the U.S. economy is posed to attract this type of capital.

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Clark Wilson on CLEBC’s Most Prolific Volunteers List

Clark Wilson would like to congratulate our lawyers, Diane Bell, Q.C., Veronica Franco, Mark Weintraub, Q.C. and Pat Williams for being mentioned on the Continuing Legal Education Society of BC’s Most Prolific Volunteers list from 1996 to 2016. They are dedicated volunteers and have participated in the areas of Alternative Dispute Resolution, Family Law, Strata Property and Estate Litigation.

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Temporary Foreign Worker Inspections on the Increase

Whilst the Federal Government is contemplating changes to the Temporary Foreign Worker Program (TFWP) to alleviate skill shortages employers are experiencing across Canada, it is also focusing on compliance through a significant increase in the number TFWP inspections it is carrying out.

An inspection can be triggered at random, by a whistleblower or, as is more often the case when an employer that has previously used the TFWP applies for a new Labour Market Impact Assessment (LMIA).

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Congratulations to Justin Jakubiak for being selected as a Finalist in Expert’s Rising Stars – Leading Lawyers Under 40

Congratulations to Fogler, Rubinoff Partner Justin Jakubiak for being selected as a Finalist in Expert Rising Stars – Leading Lawyers Under 40 competition.

The Rising Stars competition showcases Canadian lawyers that have an outstanding track record of success with complex transactions, contributed to their communities and profession and demonstrated leadership within their law departments. Finalists were also selected for being team players, who demonstrated business acumen and adaptability to change.

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