Shoosmiths’ Public Inquiries team is delighted to present a series of podcasts in respect of reflections and experiences of the COVID-19 pandemic. Hosted by Hayley Saunders and Alex Friston, we are delighted to be joined by a variety of speakers, each bringing something different to the table in relation to impacts, views and then thoughts towards the Public Inquiry, which is set to commence its first public hearings on 13 June ...
April 17, 2023 By: Meghna Parikh ALERT: Recent guidance from the Food and Drug Administration (“FDA”) clarifies a procedural issue for premarket submissions related to cybersecurity of medical devices and emphasizes the importance of collaboration between the FDA and medical device manufacturers. Providers using medical devices in their practice should pay attention to these rulings because they impacts the providers’ ability to educate and engage their patients ...
On March 31, 2023, Governor Andy Beshear signed Senate Bill 47 making medical marijuana use and sale legal in Kentucky, effective January 1, 2025. [i] Kentucky now joins at least 37 other states that have legalized medical marijuana. The newest piece of legislation comes on the heels of Governor Beshear signing two executive orders related to cannabis in November of 2022 ...
On March 22, 2023, the Centers for Medicare & Medicaid Services (“CMS”) updated its guidance and survey process for home dialysis services in nursing homes.[1] The updated guidance is based on comments, questions, and feedback received from state survey agencies, the dialysis community and other stakeholders since CMS initially issued guidance in 2018 ...
Back in March 2022, a furore erupted over the mass redundancies by P&O Ferries of its workers and their replacement with an international crew on much lower wages. Amidst all the calls for changes to prevent ‘fire and rehire’ tactics, the only relevant change to employment legislation to have made it onto the statute book so far is The Seafarers' Wages Act 2023 (SWA 2023), which came into force on 23 March 2023 ...
Shoosmiths’ Public Inquiries team is delighted to present a series of podcasts in respect of reflections and experiences of the COVID-19 pandemic. Hosted by Hayley Saunders and Alex Friston, we are delighted to be joined by a variety of speakers, each bringing something different to the table in relation to impacts, views and then thoughts towards the Public Inquiry, which is set to commence its first public hearings on 13 June ...
Derby has today (21 March 2023) been named as the national headquarters of Great British Railways (GBR) – a key moment in the government’s plan to reform the rail network. Commenting on the announcement, Michelle Craven-Faulkner, partner and rail lead at Shoosmiths, said: “The long-awaited headquarters of Great British Railways has finally been announced ...
The Department of Health and Human Resources (“DHHR”) was West Virginia’s largest executive agency until the Legislature passed House Bill 2006 earlier this month. For several years now, West Virginia lawmakers have been looking into how to handle the enormous agency, improve its function and oversight, and improve the management of the wide range of health and social programs administered by the DHHR. With an annual budget topping $7 ...
On March 8, 2023, the Oregon Senate passed Senate Bill 592, which, if passed by the House and signed by the governor, would significantly increase the penalty amounts that the Oregon Occupational Safety and Health Division (Oregon OSHA) could impose on an employer for workplace safety violations. In addition, SB 592 would require Oregon OSHA to conduct comprehensive inspections of a workplace under specific circumstances, greatly expanding the number of inspections that an employer could face ...
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 ...
The Republic of the Union of Myanmar intends to promote foreign investments in the electric vehicle sector in Myanmar by means of a mix of legal and policy initiatives aimed at incentivizing such investments. For the purpose of this article we have considered the year 2022 as the most critical year for legal regulations on electric vehicles (“EVs“) and have pivoted our discussion on legal developments prior to, during and after 2022” ...
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 ...
Recent months have seen sustained industrial action in the rail sector. On 20 February 2023, the government launched a 12-week consultation on setting minimum service levels for passenger rail. Unlike in many European countries, there are currently no limits in the UK on the number of employees who are able to take part in strike action together ...
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 ...
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 ...
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") ...
There are so many things to celebrate following the news announcement earlier this week that GWR had purchased Vivarail’s assets following it having sadly entered into administration at the end of last year. Naturally the saving of a number of jobs is great to hear but in addition the protection of the highly innovative technology which will ultimately help to support the introduction of battery powered trains onto our network has to be a good thing ...
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 ...
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 ...
Buoyed by consumer demand and legislative support, respondents to Dykema’s 2023 Automotive Trends survey enter the year in a period of cautious innovation. After analyzing survey responses, the firm's 2023 Automotive Trends Report compiles insights from key decision-makers to understand what trends will have the greatest impact on the automotive industry in the following year and beyond ...
On December 2, 2022, President Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act (“Marijuana Research Act” or “Act”) into law. The Act aims to help facilitate research on marijuana, directs the Drug Enforcement Administration (DEA) to follow new procedures to register practitioners to conduct marijuana research, and improves the supply of marijuana for research ...
Texas is increasingly a purple political state. The motto of the state's capital city implores its citizens to keep it weird.[1] Recent polling shows that Texans overwhelmingly support medical cannabis.[2] Every one of Texas' neighboring states has a real medical cannabis program ...
