In less than 4 months the Priips-Kid regulation will come into force. The exercise of ensuring compliance with this regulation is not an easy one ...
The Centers for Medicare & Medicaid Services (CMS) recently released a final rule, which will require hospitals to publicly disclose pricing information, effective January 1, 2021 ...
Impact on the activity of the pharmaceutical industry At the end of 2021, two laws were published to regulate the general framework for the prevention of corruption in the activity of companies: (i) Decree-Law 109-E/2021 of 9 December, which establishes the general rules for the prevention of corruption (“RGPC”) and (ii) Law 93/2021 of 20 December, which creates rules to protect whistleblowers (“RJPDI”) ...
The FDA recently issued final guidance regarding the size, shape, and other physical characteristics of generic-manufactured tablet and capsule dosage forms. The guidance noted that differences in physical characteristics of a dosage form could affect patient compliance and acceptability of medication regimens, or could lead to medication errors. The main reason for the FDA’s guidance appears to be that many patients can experience difficulty swallowing tablets and capsules ...
A case note by Elyse Diong Tze Mei. INTRODUCTION The recent case of Bellini Resources (M) Sdn Bhd v Mohamad Zaini bin Md Taha1 sets out the criteria for the preservation of the status quo pending trial where the ownership of a trade mark is in dispute ...
President Joe Biden announced Thursday, Sept. 9, that in the coming weeks, companies with 100 or more employees will be required to ensure their employees are vaccinated against COVID-19 or test negative for COVID-19 at least once a week.[1] Additionally, employers must provide employees time off to get vaccinated and to recover from any side effects. Press Secretary Jen Psaki previewed the forthcoming requirements in her briefing to the press on Thursday ...
The U.S. District Court for the Eastern District of Virginia recently overturned the United States Patent & Trademark Office ("USPTO") interpretation of the patent term adjustment ("PTA") statute in Exelixis, Inc. v. Kappos. Similar to Wyeth v. Kappos, where a previous USPTO interpretation of the PTA statute was overturned, the Exelixis decision promises to add months and even years to the patent term of many patents ...
At any hour, your company is vulnerable to cybercriminals aiming to cripple your operations. The repercussions are vast, from productivity loss to compromising sensitive information, which erodes trust with customers and employees alike. The financial toll and reputational harm can be severe and lasting. Whether facing a widespread assault or a precise strike, these attacks are escalating in frequency, sophistication and financial impact ...
Plaintiffs’ counsel in pharmaceutical product liability cases continue to pursue depositions of company sales representatives and seek to elicit testimony supporting their common theme that pharmaceutical companies disregard the health and safety of their consumers in the dogged, single-minded pursuit of sales and profits ...
On 6 April 2022, Shoosmiths hosted the second in a series of webinars about the UK COVID-19 Public Inquiry. The webinar focussed on the current status of the inquiry and gave practical tips for potentially interested parties. Hosted by Hayley Saunders (Partner), the webinar included talks by Charles Arrand (Partner), Alex Friston (Associate) and Hannah Frost (Associate) ...
Food producers can breathe a sigh of relief, at least temporarily, thanks to efforts by the California Chamber of Commerce resulting in a preliminary injunction barring the State of California and all private plaintiffs from filing any new Proposition 65 lawsuits targeting acrylamide in food and beverage products. On March 31, 2021, Chief United States District Judge for the Eastern District of California, Kimberly J ...
The legal status of CBD, a naturally occurring compound found in the cannabis plant, is murky. Certain Member States are more restrictive about it than others. The Court of Justice of the EU has very recently provided clarification in the context of a preliminary ruling (case C-663/18 of 19 November 2020). This case revolves around CBD’s ban in France, after it had been imported from the Czech Republic where it was lawfully produced ...
On June 10, 2021, the Standing Committee of the National People’s Congress adopted the Anti-Foreign Sanctions Law (the “Anti-Sanctions Law”) ...
Thailand is at a powerful crossroads in its economic development. After several decades of consistent growth, it is now preparing to finally break through and become a high-income nation. To do this, it is focusing on smart industry. A high-income Thailand is one driven by technological progress, so the government has begun pouring money into robotics and automation ...
Seemingly overnight, flights and hotels emptied, and state and local governments began ordering restaurants, gyms, bars, and other “non-essential” businesses to close or to significantly curtail operations. Unemployment skyrocketed, and businesses began calling out for relief. In response, the government has proposed multiple initiatives to help stabilize businesses hit hard by current events, especially those in the hospitality industry, many of which are also franchises ...
Within hours of the U.S. Supreme Court’s decision overturning Roe v. Wade, Ohio’s Heartbeat Bill, originally passed in 2019, became effective when the U.S. District Court, Southern District of Ohio, lifted its long pending injunction against the Ohio law ...
On 26 May 2020, Dubai Economy published the “Post Eid al Fitr” reopening Guidelines which took effect from Wednesday 27 May 2020 and include updates to the protocols for the wholesale and retail trade including salons and barbershops as well as valet parking. The Guidelines also provide tailored reopening protocols for cinemas, kids salons, auction houses, outsourced government service centres, and various entertainment sectors ...
On October 16, 2003, the Health Insurance Portability and Accountability Act (“HIPAA”) requires employer-sponsored group health plans and others to be in compliance with the Transaction and Code Sets (“TCS”) standards for electronic transactions adopted by the Department of Health and Human Services (“HHS”). The federal government has been warned of potential disruption in the claim submission and payment cycles because the health care industry remains substantially non-compliant ...
The U.S. Food and Drug Administration (FDA) recently announced new steps it is taking to determine a framework for lawful marketing of appropriate cannabis and cannabis-derived products.[i] As expressed in the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), the FDA has the authority to regulate products containing cannabis or cannabis-derived compounds ...
Port districts in Washington now have broad authority to extend broadband into unserved areas. ESHB 1336 amends RCW 53.08.370 to grant ports broad authority to provide wholesale and retail telecommunication services within district boundaries and in some cases, by agreement with other government entities outside district boundaries ...
The retail sector has been one of the sectors most affected by the COVID-19 pandemic and as a result employers therein might be considering dismissing employees for economic or technical reasons. Employers must be aware that most joint committees in the retail sector have entered into collective bargaining agreements (CBAs) obliging employers to first take measures to avoid dismissals and, if dismissals cannot be avoided, to comply with a specific procedure ...
In a decision that could be a game-changer for cookie and candy manufacturers, the Third Circuit has recently denied trade dress protection for the shape of the popular Pocky cookie. The Pocky is a long, thin Japanese cookie stick that is almost completely dipped in chocolate, except for the very bottom. Ezaki Glico created the Pocky in 1966 and obtained two trade dress registrations to protect the configuration of the cookie ...
The Treasury Department has announced further extensions for medium-sized and large-sized employers for compliance with the “employer mandate” of the Affordable Care Act (“ACA”). The employer mandate requires employers with a threshold level of employees to provide affordable health insurance to 95% of their full-time employees. Under the ACA, a full-time employee is defined as any employee who works on average 30 or more hours per week ...
We’re excited to announce that Shoosmiths is one of the partners behind Platform – a six-month campaign that aims to make town centre property more accessible to communities and businesses. Being based in thirteen locations across the UK and with many clients whose businesses rely on a successful town centre, Shoosmiths is heavily invested in the issue of urban revival ...
