On June 1, 2023, China's Ministry of Science and Technology ("MOST") officially released the Implementation Rules for the Regulation of Human Genetic Resources Administration ("Implementation Rules"), which will come into effect on July 1, 2023 ...
On November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS OIG) issued Special Fraud Alert: Speaker Programs (Fraud Alert) to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies ...
The U.S ...
In this report, you will find a summary of two important decrees published yesterday in the Official Gazette. Regulatory Decree of Law No. 27,350 of medical and scientific research on the medicinal use of the cannabis plant and its derivatives By means of Executive Branch’s Decree No ...
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 ...
More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was reevaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities.The bills reawakened a debate about the pros and cons of POHs ...
Should States Embrace Telehealth Parity? Parity in telehealth is the notion that health services provided via telehealth technology should be treated equally as health services provided face-to-face. This is consistent with coverage parity, which requires payors to provide the same level of insurance coverage for patient encounters and services, while payment parity (a.k.a ...
Health and safety issues in the agricultural and rural sector are a matter of considerable concern. The Health and Safety Executive (HSE) is urging farmers to make safety a priority to reduce the number of injuries and fatalities in the sector. This recent campaign was prompted by four fatalities over a fortnight, coming only weeks after Farm Safety Week ...
In June 2022, at one of the annual meetings of the Employment, Social Policy, Health and Consumer Affairs (“EPSCO”) Council, health ministers expressed their concerns regarding the legislative transition to Regulation (EU) No 2017/745 of the European Parliament and of the European Council of 5 April 2017 on medical devices (“MDR”) and to Regulation 2017/746 of the European Parliament and of the European Council of 5 April 2017 on in vitro diagnostic medical devi
Historically, businesses involved in the U.S. defense industrial base have been protected from foreign direct investment by the Committee on Foreign Investment in the U.S. (CFIUS) — but changes to U.S. laws and regulations on foreign direct investment have expanded the types of businesses that are now protected ...
Post-Brexit, it’s now even more important for farming families to understand how changes to direct payments and valuation of farmland can affect succession, asset protection and family disputes. We explain what you need to know. Leaving the EU resulted in the UK leaving the EU’s Common Agricultural Policy (CAP), which paid farmers direct payments and has been a significant source of income for many farmers ...
On May 24, 2022, Schwabe and Columbia Bank hosted the “Getting Ahead of Agriculture's Rising Wages and Tightening Labor Market” seminar to assist those working in Oregon’s agricultural industry to address concerns over rising wages and the tight labor market. Attendees heard from a group of industry professionals on a selection of relevant topics. The seminar was informative, engaging, and a big success ...
Geographical indication of origin, this very peculiar form of industrial property protection, has undergone a revival phase over the past few years, thus becoming more omnipresent not only within the circles of interest, but also amongst the Serbian public at large. Although, up to this day, there are only a few dozen geographical indications of origin registered before the Serbian Intellectual Property office, for a country of little over 7 million spread over 80 ...
A March 7, 2013 piece on Morning Edition, the morning news program from National Public Radio, raised a lot of questions. “In A Grain Of Golden Rice, A World Of Controversy Over GMO Foods” told the story of golden rice, a beautiful yellow rice enhanced with beta-carotene, or Vitamin A. This rice was ostensibly developed to be grown in developing countries, where foods high in Vitamin A either are uncommon or are expensive ...
On July 11, 2018, then-U.S. Food and Drug Administration Commissioner Scott Gottlieb made a public statement about the agency’s efforts to advance the development of gene therapies.[1] Gottlieb pointed out that the FDA has approved three separate gene therapy products and the agency has issued six scientific guidance documents intended to serve as building blocks of a modern, comprehensive framework for how the FDA can advance the field of gene therapy ...
In the fourth quarter of 2023, Sen. Raphael Warnock, D-Ga., made industry news, important banking and financial rule changes were implemented, and Georgia's Department of Banking and Finance quietly issued important new regulatory guidance on a handful of topics. Warnock Addresses Banking Committee, Introduces Legislation First, during a three-plus hour U.S ...
Activists are recasting risk in a way that can only damage industry Last August, a California jury awarded plaintiff Eva Echeverria a total of $417m in compensatory and punitive damages in a lawsuit against Johnson & Johnson (J&J). Her case was that the company should have warned consumers that studies had found an inconclusive correlation between ovarian cancer and talcum powder ...
There is concern the race to achieve carbon net-zero is leading to the loss of productive agricultural land to forestry. Investors recognise land with planting potential as an excellent investment, which has had a distorting effect on land values. To some extent, this is simply the operation of market forces. A landowner with an unprofitable farming business may well be tempted to sell land to a forestry investor and there are no restrictions on their ability to do so ...
The establishment by the Scottish Government of a food security task force is a necessary and timely response to the war in Ukraine. In addition to the harrowing humanitarian crisis, the conflict has prompted significant concern among food producers. The UK food sector and consumers are currently facing a perfect storm just as we begin to emerge from the pandemic ...
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 ...
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 ...
In two decisions on Friday, the Federal Circuit clarified the law of obviousness-type double patenting (ODP) and provided certainty to biopharma patent owners. In Novartis AG v. Ezra Ventures LLC, the court held that ODP does not invalidate an otherwise valid patent term extension (PTE) granted under 35 U.S.C. § 156 (extending the term of a pharmaceutical patent to compensate for regulatory delays). And in Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc ...
Biosimilar developers have been aggressive in filing petitions for inter partesreviews of biologics patents before the Patent Trial and Appeal Board, many ofthem preceding the filing of a marketing application. Such early IPRs are attractiveto biosimilar makers, because they provide a chance to challenge innovator patentsyears before the biosimilar maker files a marketing application with the U.S. Foodand Drug Administration ...
FDA Warns Consumers About Unauthorized Fraudulent COVID-19 Products.The FDA issued a Consumer Update advising consumers to be beware of fraudulent coronavirus tests, vaccines and treatments. The FDA has seen unauthorized fraudulent test kits for COVID-19 being sold online. Currently, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19 ...
On September 9, 2014, the U.S. Food and Drug Administration (FDA) published the inaugural “Purple Book,” a list of approved or “licensed” biological products, including all biosimilar and interchangeable biological products. The Purple Book is more formally known as “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.” The Purple Book is meant, at a fundamental level, to be the biological equivalent of the “Orange Book ...
