The U.S ...
The FDA issued immediately-in-effect guidance to accelerate the development of certain laboratory tests for the urgent need caused by SARS-CoV-2. The FDA provides recommendations, among others, for serological tests, puts forth a policy for states to take responsibility for tests, and announces enforcement discretion for commercial manufacturers using new commercially developed tests prior to the FDA granting an emergency use authorization, under certain circumstances ...
To help prevent disruptions in the food supply-chain during the COVID-19 pandemic, the FDA issued a temporary policy for Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements. The policy states that the FDA will temporarily not enforce FSMA supplier verification onsite audit requirements if other appropriate supplier verification methods are used instead ...
Regulators Expand Opportunities for Telehealth Services Under COVID-19 Shadow By: Phil Kim, Kayla Cristales, and Jennifer Kreick As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehealth services ...
As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehealth services.Telehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient’s health ...
As COVID-19 continues to spread, CMS has issued guidance to various healthcare providers, including, among others, home health agencies, nursing homes, and hospitals that are caring for the nation’s most at-risk patient populations.The guidance is intended to curb transmission and ensure healthcare providers have the information and resources necessary to respond to patient needs ...
The currently unstoppable strong spread of COVID-19 and the resulting restrictions on public life, such as quarantine measures and curfews, which are imposed in EU Member States and worldwide and which are sometimes very drastic, are also increasingly impairing the ability to work and communicate. In the meantime, various IP Offices have also reacted to this. 1 ...
In the advent of DNA testing, companies such as Ancestry.com and 23andMe have made it easy and convenient to submit DNA samples for testing from your own home. This type of genetic—also known as genomic—testing has been applied to a variety of uses, including paternity determinations and the discovery of genetic ancestors and relatives ...
With the Corona crisis, countries such as Germany, France and the Czech Republic have already announced bans on exports of protective gear to avoid shortages at their countries. But is this in conformity with the principle of free movement of goods as provided for in articles 34-36 TFEU? This principle is one of the cornerstones of the European Union's internal market which implies that national barriers to the free movement of goods within the EU need to be removed ...
The Department of Agriculture (USDA) announced in late February that it's delaying enforcement of certain requirements set forth in its Interim Final Rule (IFR) on the Domestic Hemp Production Program (84 FR 58522) under certain circumstances until October 31, 2021, or until publication of the final rule on such hemp production program, whichever occurs first ...
The Danish Regions have proposed a new model for establishing a so-called Treatment Council which is to assess whether the price of treatments and health technology measure up to the effect for the patients. The model will now go out for consultation. The purpose and scope In their proposal, the Danish Regions want to establish a Treatment Council which is to make recommendations regarding the use of medical devices and health technology ...
Recently, in Amgen Inc. v. Hospira, Inc.,[1] the Federal Circuit clarified the limits of the Safe Harbor defense in cases involving patented manufacturing methods. In a case brought in the District of Delaware, Amgen alleged that Hospira infringed several patent claims over methods of manufacturing erythropoietin (EPO), a biologic drug used to treat anemia ...
Over the past years, the Minister of Agrarian Affairs and Spatial Planning/ Head of the National Land Agency (“Minister”) has issued several regulations on location permits due to the progressive system established by the government for the efficiency of investments and licensing. After the Online Single Submission (“OSS”) system became applicable, the Minister issued Regulation No ...
On Oct. 31, 2019, the United States Department of Agriculture (USDA) published its highly anticipated interim final rules, establishing the USDA Domestic Hemp Production Program to be administered by the Agricultural Marketing Service (AMS) ...
Agribusiness: STJ Recognizes the Co-Existence of Intellectual Property Rights from the IP and Plant Varieties Acts over Transgenic Soybeans On October 9, 2019, the Superior Court of Justice (“STJ”) unanimously denied Special Appeal No. 1.610.728/RS, establishing an understanding that entitles holders of GMO patents over soybeans to charge royalties for the use of their seed by farmers outside the scope of the Plant Varieties Act ...
California Assembly Bill No. 205 was approved by Gov. Gavin Newsom on July 9, 2019. Assembly Member Tom Daly, who represents California’s 69th district of Orange County cities Santa Ana, Anaheim, and Garden Grove, introduced AB-205 to expand the definition of “beer” under Business & Professions Code §23006, which is part of the Alcohol Beverage Control Act. The new law is set to go into effect on Jan. 1, 2020 ...
As seen on Law360: The 2018 Farm Bill[1] relaxed restrictions covering hemp-based cannabis products, and it is causing a shift in business strategies in the industry. Instead of a full prohibition of trademark registrations covering cannabis goods or services, a narrow range of filings is now permitted, so long as they conform to the requirements of the Farm Bill and the latest USPTO guidelines ...
Last month marked the 50-year anniversary of one of the more infamous and impactful environmental disasters to occur in the United States. On June 22, 1969, the Cuyahoga River, which runs through the heart of Cleveland before emptying into Lake Erie, caught fire for the 13th time. Time magazine ran a story that highlighted the river’s severe pollution ...
On Monday, June 3, Governor Gretchen Whitmer and the Michigan Department of Agriculture and Rural Development (MDARD) announced MDARD’s decision to allow for commercial solar energy development on land currently enrolled in the Farmland and Open Space Preservation Program, commonly known as PA 116. PA 116 was established in 1975 and is designed to preserve farmland and open space in Michigan ...
For businesses who care about their brands, Pofma may be not be such a bad idea after all.Beyond Meat Inc. makes cows happy and cardiologists sad. Its Beyond Burger uses no meat and has no cholesterol, and contains less fat, fewer calories and more protein than a typical burger ...
The Scottish Government, SEPA and industry have identified significant opportunities for the growth of the finfish aquaculture sector in Scotland. This expansion is an express policy objective of the Scottish Government, and was confirmed through the National Marine Plan published in 2015. Nevertheless, whilst there has been some growth in the sector since the plan’s publication, the sector has yet to realise its full potential ...
Whatever your views on Brexit, the deferment of the UK’s leaving date from the EU provided British industry some welcome breathing space to prepare for Brexit. Given the issues that still divide the two main political parties, the UK may yet leave the EU without a deal on 31 October ...
Scotland’s countryside offers a vast range of property investment options, from houses and cottages to farms and country estates. However, when buying a rural property it is important to consider various issues that may be taken for granted in the purchase of a property in an urban area. 1 ...
Coordinating cross-border due diligence is a key skill that more often than not underpins complex, multi-jurisdictional merger and acquisitions (M&A) and private equity (PE)-led transactions. Where due diligence really adds value is in the early stages of the transaction, when local knowledge and expertise are vital to understanding the context of data room information ...
