Prepare for another big shift in health care operations. On January 30, 2023, President Joe Biden announced he would not extend the COVID-19 Public Health Emergency (PHE) beyond its current expiration date of May 11. The PHE was declared by former President Donald Trump in March of 2020 as COVID-19 began to spread around the nation. The waivers and other regulatory changes instituted in its wake have impacted nearly every facet of health care services ...
Regents of the University of Minnesota v. Gilead Sciences, Inc., Appeal No. 21-2168 (Fed. Cir. Mar. 6, 2023) The Federal Circuit’s only precedential patent opinion this week focuses on the written description requirement in the context of an anticipation analysis in the chemical arts. Specifically, it concerns whether disclosures in asserted prior art were sufficient to disclose a claimed molecular structure ...
On January 19, the Federal Trade Commission (FTC) published its proposed rule barring most non-compete agreements that would apply to employees. We previously summarized the proposed rule here and here. The original deadline for comments on the proposed rule was March 20. On March 6, the FTC announced it is extending the deadline to submit comments to April 19. As of March 9, a total of 16,965 comments (8,848 electronically) have been received on the proposed rule ...
Compliance related themes have become a widely discussed and increasingly important topic for corporates around the world. Increased ESG requirements and awareness have made companies rethink what responsible corporate everyday life looks like. At the same time corporate crimes and, for example, cyber-attacks and data breaches are ever increasing and may lead to detrimental consequences on business ...
Chapter 8: Technical Barriers to Trade This chapter provides rules to facilitate trade by eliminating unnecessary technical barriers, improving transparency, and promoting greater regulatory cooperation. It applies to the elaboration, approval and application of technical regulations, standards, conformity assessment procedures and trade authorization for pharmaceuticals, cosmetics and medical devices ...
After a long pause, we are pleased to release a new version of our regulatory Guides. To cover the gap since the last publication, we would like to devote this Guide to an overview of key changes and trends that took place in 2022. 2022 was a challenging year for many companies working on the Russian market as well as for the Russian market and economy as a whole ...
Dear Readers, ALRUD Regulatory practice has prepared a new version of our regulatory Guides. This Guide is devoted to an overview of key changes and trends that took place in 2022. The review was published with the participation of ALRUD experts - Maxim Alekseev, Senior Partner and Head of ALRUD Regulatory practice,Dina Kravchenko, Senior Associate, andBoris Pribylov, Senior Associate. Follow the link below to learn more ...
This is the third alert in a series designed to inform physicians and other health care providers of what to do in the event of a State Medical Board of Ohio (“Board”) investigation, how to potentially avoid an investigation and what to expect during a license disciplinary case ...
Illinois has the strictest biometric privacy law in the country with the Biometric Information Privacy Act (“BIPA”). The BIPA requires employers who collect employees’ biometric data to follow a number of protocols. These protocols include (1) maintaining a written policy about the collection and storage of employee biometric data, (2) providing employees with written notice of that policy, and (3) obtaining informed consent from employees to collect biometric data ...
Nearly 106,000 Americans are currently on waiting lists for donor organs and 17 die each day while waiting. The holy grail for rising to meet this demand and end this suffering will be the ability to “print” the organs, muscles, and tissues from individually grown cells, lowering the need for human donors and the complicated and sometimes unbearable stress that goes along with donor wait lines ...
Over the weekend, the EU announced its 10th sanctions package against Russia as a response to the invasion of Ukraine. The timing of the 10th sanctions package coincides with the anniversary for Russian invasion of Ukraine. The measures implemented in the new sanctions package include, inter alia: Additional sanction listings of 121 individuals and entities ...
On February 20 of this year, the Public Health Institute (hereinafter "ISP"), approved through Exempt Resolution No. 401/23 the technical guide for the sanitary registration of allergens with the purpose of establishing the guidelines and requirements for the sanitary registration of these products (the "Guide") ...
On February 20 of this year, the Public Health Institute (hereinafter "ISP"), approved through Exempt Resolution No. 405/23 the technical guide on homeopathic products with the purpose of providing the guidelines and requirements for the request of the sanitary registration of these pharmaceutical products in order to provide complete and updated information that supports the quality, safety and efficacy of these products (the "Guide") ...
February 27, 2023 By: Leah Lively and Jack Darrington All employers should be aware of the recent decision by the United States Supreme in Helix Energy Solutions Group Inc. v. Hewitt dealing with exemptions under the Fair Labor Standards Act (“FLSA”). The Hewitt court held that a well-compensated employee paid a daily rate, rather than a fixed weekly or monthly salary, was not exempt from the FLSA and its rules regarding overtime pay ...
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, Appeal No. 2023-1186 (Fed. Cir. Feb. 24, 2023) In this week’s Case of the Week, the Federal Circuit affirmed a permanent injunction requiring appellant Jazz Pharmaceuticals to de-list its U.S. Patent No. 8,731,963 from the Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalents Evaluation publication, colloquially known as the “Orange Book ...
While a recent Pennsylvania ruling issued In February 2023 has been hailed as a victory for the underfunded school districts in the state, it could be a long road ahead before meaningful change makes its way to the students, teachers, and schools who need it the most ...
The Equal Employment Opportunity Commission (“EEOC”) plans to prioritize its efforts to correct discrimination and harassment in the construction industry following a review of data that revealed the construction sector to be one of the most challenging areas in terms of discrimination and harassment cases ...
On December 29, 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”) was signed into law.[1] MoCRA is the first federal cosmetics law since 1938 and will impose a number of new requirements on cosmetic products and the facilities where they are manufactured. Specifically, MoCRA requires the Food and Drug Administration (FDA) to implement enhanced oversight and regulation of cosmetic manufacturing facilities and products by December 29, 2023 ...
On February 21, 2023, the National Labor Relations Board (“NLRB”) overruled two Trump-era decisions, restoring earlier precedent concerning the legality of confidentiality and non-disparagement provisions in severance agreements ...
Introduction Recent years have seen the UAE making regular updates to its laws in order to guarantee a legal regime that is forward-looking, and consistent with international standards and principles. The leaders of the UAE have been particularly cognizant of the need to have a robust criminal law regime to encourage legitimacy in business, and dissuade any unscrupulous activities that could reflect negatively on the UAE as a determined and fast-developing economy ...
Over the past few weeks, the investigation of sexual misconduct cases by the State Medical Board of Ohio (“Board”) has continued to make headlines across Ohio. Due to an increased public outcry as a result of the recent media attention, as well as the previous revelations of the Board’s handling of the Dr ...
On the occasion of Children’s Day on January 12, 2023, Kudun and Partners launched an internal donation drive on January 12 to rally firm members to support children’s centers in Bangkok and Hat Yai. The donation drive was initiated as part of the firm’s continuous aspiration to contribute back the society ...
Lite-Netics, LLC v. Nu Tsai Capital LLC, Appeal No. 2023-1146 (Fed. Cir. Feb. 17, 2023) In an appeal from the U.S. District Court for the District of Nebraska, the Federal Circuit addressed whether the district court properly granted a preliminary injunction restricting Lite-Netics, LLC’s patent-related speech ...
