On December 7, 2018, the Food and Drug Administration (FDA) released a Proposed Rule that clarifies procedures and criteria for the de novo medical device clearance pathway. In a statement accompanying the Proposed Rule, FDA Commissioner Scott Gottlieb stated FDA believes the Proposed Rule will help facilitate classification of innovative low- to moderate-risk novel medical devices by providing more structure, clarity, and transparency to the de novo pathway ...
On Nov. 19, 2018, the Bureau of Industry and Security (BIS) of the U.S. Department of Commerce issued an Advance Notice of Proposed Rulemaking[1] requesting public comment on criteria for identifying emerging technologies essential to U.S. national security that would be subject to increased export controls ...
Today the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (NPRM) that will end HRSA’s delays in implementing a January 5, 2017 final rule concerning 340B drug price calculations and civil monetary penalties (CMPs) against manufacturers who knowingly and intentionally overcharge 340B covered entities for 340B drugs (the Final Rule) ...
Months into the United States’ trade dispute with China, and there is no end in sight to the dispute. There are three significant deadlines for U.S. importers to consider involving the tariffs the U.S ...
Lawyers are often criticised for using overly complex legal and technical wording in contracts. The purpose of a contract is, amongst other things, to clearly set out the rights and obligations of the contracting parties, and to limit uncertainty during the particular project. To this end, it is important to use plain English in contract drafting and as a general rule, to use short sentences, defined terms and a clear and logical structure ...
Earlier this year, in Kim v. Toyota Motor Corp., the California Supreme Court delivered a significant win to product manufacturers concerning the admissibility of industry custom and practice evidence in a strict product liability design defect action. Haynes and Boone, LLP Partner M.C ...
As a business owner in the Pacific Northwest, you likely have heard of the changes to California’s regulations regarding warning labels on consumer products, Proposition 65, which takes effect August 30, 2018. Your business may be affected by the changes if your business conducts any consumer product-related business in California ...
The Industrial Court is a creature of statute. In determining a particular dispute, the Industrial Court must act in accordance with the purposes and express provisions of the Industrial Relations Act 1967 (“Act”). The Court must also act according to “equity, good conscience and the substantial merits of the case without regard to technicalities and legal form” [1] ...
In North Midland Building Ltd v Cyden Homes Ltd, the Court of Appeal held that an express contractual term allowing an employer to levy liquidated damages for periods of concurrent delay took precedence over a common law principle known as the prevention principle. Background Cyden Homes Limited (CH) employed a contractor, North Midland Building Limited (NMB), to design and build a large house in the Midlands, under a JCT Design and Build construction contract ...
Getting the Deal Through – Shipbuilding is part of the series of Getting the Deal Through law guides published by Law Business Research that provide an overview of specialist areas of the law in a variety of international jurisdictions. It is published annually and the seventh edition, covers 13 jurisdictions. Leading practitioners from each jurisdiction answer the same key questions ...
The manufacturer of a product generally has a duty to warn the end-consumer of any serious risks associated with that product. In the context of prescription drugs and medical devices, however, the “learned intermediary” doctrine holds that the manufacturer need not warn the end-consumer (i.e., patient). Instead, the manufacturer discharges its obligations by warning the prescribing physician ...
The Department for Digital, Culture, Media and Sport (DCMS) has published the Creative Industries Sector Deal aimed at making the UK the best place in the world for businesses in the creative industries. This is the latest sector deal to flow from the government's Industrial Strategy White Paper after sector deals for life sciences and the automotive industry were announced in late 2017/early 2018, respectively ...
This article provides a brief review of MSHA enforcement data and a look at MSHA’s regulatory agenda. MSHA Enforcement Data (data from January 1, 2017 to December 31, 2017) MSHA issued 104,412 enforcement actions to mine operators in 2017, an increase of approximately 11,793 or 11.3 percent from 2016. Of these, 58,083 (or 55.63 percent) were issued to metal/nonmetal operators while 46,329 (or 44.37 percent) were issued to coal operators ...
Strong contracting processes and communications which establishes clearly the expectations of each of the parties reduces disputes and costs and strengthens relationships. The key to strong contracting processes is to approach contracts in a holistic manner making sure all documents interconnect in a logical uniform manner. Because manufacturing processes can be complex, this is often not as easy as it sounds ...
The U.S. International Trade Commission (“ITC”) issued a determination at the end of 2017, finding that solar panel imports are hurting domestic businesses that operate in the solar industry. The ITC’s determination was issued in connection with a trade case filedby a Georgia-based company, Suniva, Inc., shortly after filing for bankruptcy protection. SolarWorld Americas, Inc. joined Suniva’s petition ...
Understandably, representatives for the oil & gas sector were keen to input into the strategy. Stakeholders believe that a purposeful collaboration between the industry and Government and a commitment to a combined effort will ensure that the infrastructure already in place can be used to benefit the UK in the future. Green Paper The green paper set out proposals for discussion and consideration and was an invitation to others to contribute ...
It starts with the best of intentions: A startup medical device company has just sold to a larger enterprise with an established sales team and customer base and no longer needs distributors. A consumer packaged goods company has just bought a brand and needs to transition to a new team of brokers. A growing company is finally ready to take its supply chain captive, including the distribution of products to customers, and no longer needs small distributors or sales representatives ...
The Chilean Economic Development Agency, Corfo, and the Foreign Investment Promotion Agency, InvestChile, have announced the opening of the first call for national and foreign companies, to express their interest in manufacturing lithium products, such as battery cathodes and electrolytes. Companies that are selected will be guaranteed 25 per cent of US producer Albemarle’s lithium production at the lowest cost available in the market ...
The Oberlandesgericht Celle has recently adopted a decision that is likely to be of particular interest to hospitals which are not, in principle, public contracting authorities within the meaning of the law, but which are used by public authorities to pay more than 50 percent for the construction of hospitals pursuant to Section 99, 4 of the GWB (decision ref. 13 G 8/16). In the decided case, the client planned to modernize a hospital in three construction phases ...
Resale price maintenance and price-fixing has been and still is under scrutiny by the Croatian Competition Agency (the "Agency"). Carrying on from a number of high-profile cases, in February 2017 the Agency fined Gorenje Zagreb, a subsidiary of Slovenia's premier manufacturer of household appliances for HRK 1,557,000 (approximately EUR 206,000) ...
Industrial facility owners and operators in West Virginia should be aware of new reporting requirements that will soon go into effect. In addition to currently mandated notifications to federal, state, and local agencies after certain events occur, some facilities will soon be required to notify the state within 15 minutes of discovering specific types of emergency events or be subject to a fine of up to $100,000 ...
The recent Supreme Court of Appeal (“SCA”) case of Transnet v Total is important not only for those in the petroleum industry, but also, more generally, when it comes to aspects of competition and discrimination, as well as the impact of changes in the law on existing contracts and vested rights ...
The European Commission has opened an in-depth merger investigation into the planned acquisition of Cemex Croatia by Duna-Drava Cement ('DDC'). Registered in Hungary, DDC is jointly controlled by German construction material producers HeidelbergCement and Schwenk. DDC inter alia operates a cement plant in Kakanj, Bosnia and Herzegovina. Cemex Croatia, an arm of the international cement heavyweight Cemex, controls three cement plants in the Croatian coastal city of Split ...
