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 ...
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 ...
As per a state-owned daily publisher dated 4th April 2023, the grand opening of trademark registration will be launched on 26th April 2023 (“Grand Opening“). On the date of the Grand Opening, the applications for the old and new trademarks will be accepted for registration purposes. The mark intended for use without actual use in the Myanmar market will also be accepted as a new mark ...
On 18 January 2023, the Belgian Competition Authority (“BCA”) reimposed a fine of EUR 859,310 on three undertakings of the Caudalie group for imposing retail prices and restricting active and passive sales ...
The Law on Food Safety which was promulgated on 8 June 2022 obliges food business operators (such as food business owners or manufacturers, processors, packagers, wholesalers, retailers, and distributers) (“Operators”) to immediately notify the competent authorities of problems with the food products and cooperate with the authorities to implement measures to avoid or minimize risks caused by the food, as well as to trace, recall, and withdraw unsafe food products from the market ...
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 ...
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 ...
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") ...
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 ...
It's the final countdown to the new Consumer Duty. After what feels like a lifetime of consultations, responses and commentary on the FCAs new Consumer Duty, the final countdown is upon us. With just over 5 months to go before the Consumer Duty comes into force, the big question is.. ...
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 ...
The recently published project of the National Development Plan (“PND”) 2022-2026 “Colombia World Power of Life” embodies the objectives, goals and priorities of the National Government for the next four years. In the PND, the National Government introduces rules or regulations that would make it easier to achieve the objectives pursued ...
Is Tesco exploiting Lidl’s reputation as a discount or ‘value’ supermarket? This is what Lidl are alleging in the most recent supermarket trademark dispute. The question being put before the Court is essentially whether Tesco’s ‘Clubcard Prices’ logo infringes on Lidl’s brand logo, as both appear as text in a yellow circle on a blue background ...
An analyst estimates that the market value in 2023 for digital advertising will be US$701 billion. The EU’s Digital Markets Act (DMA) is a legislative competition law 'key' to 'unlocking' the big-data relating to digital advertising held in the ‘safe’ owned by BigTech. Advertising agencies are potentially one class of beneficiary (see link for article - The Digital Markets Act - Strategy reboot for online advertising) ...
