Legal Updates

Draft law, which is going to add rules on state registration of medical drugs, has been developed

The Ministry of Healthcare of the Russian Federation (“Minzdrav”) has prepared Draft law1 on improvement of the medical drug circulation legislation with regard to the Treaty on unified principles and rules of medical drugs circulation within the Eurasian Economic Union (“EEU”) dated 03.11.2016 No. 78.

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FDA’s New Year Resolution: Breakthrough Barriers and STeP Up Device Innovation

On December 18, 2018 the Food and Drug Administration (“FDA”) finalized guidance on its existing Breakthrough Device Program and announced plans for advancement of the Safer Technologies Program (“STeP”).  In the announcement, FDA Commissioner Scott Gottlieb emphasized the FDA’s efforts to promote innovation in medical devices that advance patient safety. This new medical device guidance could signal a year of opportunity for innovative medical device manufacturers that seek to advance patient safety.

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ASIC releases consultation paper on fees and costs disclosure regime

On 8 January 2019, ASIC released a consultation paper on reforms to the fees and costs disclosure requirements for managed investment schemes and superannuation funds. The paper is in response to the independent reviewer’s report into the fees and costs disclosure regime under the Corporations Act 2001 as amended by ASIC Class Order [CO 14/1252] and as augmented by its regulatory guidance. In this article, we outline some key points of the consultation paper.

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Fladgate’s Corporate team is further strengthened with the appointment of outsourcing and technology partner Tim Wright

Fladgate is delighted to announce the appointment of Corporate partner Tim Wright.

Tim joins having previously led the global sourcing practice group at Pillsbury Winthrop Shaw Pittman LLP in London. He specialises in complex, often cross-border, commercial, technology and outsourcing transactions, with a particular focus on the financial services, healthcare and technology sectors. He is recognised by leading directories including Chambers and Legal 500.

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Protecting Your Trade Secrets and Goodwill

Any company’s success relies in large part on the products, technologies, or processes it develops. For a smaller business, its “secret sauce” can be one of its most important competitive advantages and its most valuable asset. However, developing these coveted creations is only half the battle. The other half requires protecting a business’s goodwill and proprietary information to maintain its competitive advantage in the market and ensure customer loyalty. This half requires careful planning, as small businesses and entrepreneurs must navigate employee confidentiality agreements and restrictive covenants to protect these valuable assets.

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Connolly Gallagher Elects Aaron Shapiro to Partner

Connolly Gallagher Elects Aaron Shapiro to Partner

Connolly Gallagher LLP is pleased to announce that Aaron M. Shapiro has been elected partner effective January 1, 2019. “Aaron previously served as the Labor Relations and Employment Practices Administrator for the state of Delaware and since joining the firm in 2017 he has worked hard to build a highly respected labor law offering that we proudly provide to our valued clients,” said Arthur G. (“Chip”) Connolly III, Managing Partner of the firm.

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James E. Gallagher Elevated to Shareholder

Davis Malm is pleased to announce that James E. Gallagher has been elevated to shareholder effective January 1, 2019.

Mr. Gallagher practices in the Business Law, Employment, and Litigation areas at Davis Malm. He is a trial lawyer with experience in a range of areas, including fiduciary, securities, commercial and class action, probate, and employment litigation in state and federal courts. He also advises numerous residential and commercial condominium associations.

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Court conducts appraisal of ‘prudent lending’ clause in valuer policy

Professional indemnity insurance policies usually require a valuer to include in his or her report a ‘prudent lender’ clause.

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Marijuana Legalization Takes Another Step Forward in 2018 Elections

In the November 2018 mid-term elections, state ballot measures for the legalization of marijuana were approved in three states – Michigan, Missouri, and Utah – and rejected in one state – North Dakota.

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Roszdravnadzor will be entitled to carry out test purchases of drugs and medical devices

On December 13, 2018 Russian State Duma has passed in the third reading a draft law empowering the state healthcare control (supervision) body (Roszdravnadzor) to conduct test purchases (“Draft law”)1.

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