Those in the CBD sector should be mindful of their marketing tactics, as the FDA continues to police the industry. Manufacturers of CBD products must also evaluate their quality-control procedures to ensure safe products are hitting the marketplace. As we forecasted this past December in a previous legal alert, the U.S. Food and Drug Administration continues to referee the emerging cannabidiol (CBD) product market ...
On April 30, 2021, the U.S. Food and Drug Administration (FDA) announced it was revoking a policy related to new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The FDA stated that the previous policy announced by the Department of Health and Human Services (HHS) on Jan. 15, 2021, was being rescinded because the new policy would have required the FDA to publish redundant information about new applications of NDAs and ANDAs ...
On January 13, 2014, the Food and Drug Administration ("FDA" or "the Agency") announced the availability of a much-anticipated draft guidance on its intended regulation of product promotion conducted via social media, titled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics ...
Even before COVID-19, the Foreign Corrupt Practices Act (FCPA) was becoming increasingly tricky to navigate and was actively enforced. But in light of the pandemic, which is forcing rapid changes to the global marketplace and causing unique supply chain challenges, the risk of a costly misstep has only increased ...
We published an article on the International Sustainability Standards Board (ISSB) commenting on the publication of the exposure drafts of two International Financial Reporting Standards (the Standards). The UK Financial Conduct Authority (FCA) recently published its response welcoming the Standards. Key points The FCA stated that the Standards generally met its expectations as set out in its Strategy 2022 to 2025 ...
It is rare that FCA defendants have their legal defenses paid for, and rarer still that DOJ must bear the expense. In United States ex rel. Wall v. Circle C Construction, the Sixth Circuit held that the government must pay roughly $500,000 in legal fees and expenses the defendant incurred as a result of the government’s unreasonable litigating position ...
Yesterday, the Financial Conduct Authority (FCA) published a consultation paper on social media guidance for firms promoting financial services and products. The draft guidance does not contain anything new so far as "dos and don'ts" for promotional material - including the new rules set to come into force on 8 October this year regarding promotion of crypto-related investments (see relevant article here) ...
Earlier this year, the Court of Justice of the European Union (CJEU) reached an important decision in the case Medisanus d.o.o. v General Hospital Murska Sobota (C-296/15) concerning public procurement procedures ...
After three days of historic oral arguments before the U.S. Supreme Court, the fate of the Affordable Care Act (ACA), the momentous 2010 health reform law, is uncertain, given robust questioning of the ability of Congress to force individuals to purchase health insurance ...
Hand sanitiser production is just one aspect of business that's altered for £5bn industry, writes George Frier of Shepherd and Wedderburn The whisky industry continues to captivate consumers and entrepreneurs. Record exports continue and, within the sector, the emergence of new brands and the rejuvenation of existing brands demonstrate a vibrant sub-set of the Scottish food & drink economy ...
Yesterday, Wednesday 18 March 2020, the Norwegian Government put forward a bill which will give the Government vast authorization to fight Covid-19 and its consequences for the society. It is called the corona act. The aim is to facilitate "sound and effective measures necessary to limit the disruption of normal social functions" of the Covid-19 outbreak (article 1) ...
The controversial issue of whether employers can check their employees' temperatures has been much debated. Both the Employment Ministry and the Data Protection Authority (DPA) have recently changed their positions in this respect ...
Family Intervention Tenancies (FITs) are a new type of tenancy to be introduced by Sections 297-298 of the Housing and Regeneration Act 2008. They will be another tool for registered providers (the new term for both Registered Social Landlords and local authorities to tackle anti-social behaviour ...
Bradley’s Government Enforcement and Investigations Practice Group is pleased to present the False Claims Act: 2022 Year in Review, our annual review of significant False Claims Act (FCA) cases, developments and trends. In 2022, the government continued to utilize the False Claims Act as its primary tool to combat fraud. Though the government’s recoveries at $2 ...
The False Claims Act, 31 U.S.C. §§ 3729, et seq. (FCA) continued to be a significant focus of government and whistleblower activity in 2016. ThisYear in Review highlights several key developments, including: The U.S. Department of Justice is continuing its strong enforcement of the FCA, including recovering more than $4.7 billion in settlements and judgments in FCA cases in 2016, as well as continuing its focus on individual culpability ...
In response to the economic impact of the COVID-19 pandemic, the federal government has passed several new laws to provide trillions of dollars of funding to affected businesses and individuals. But this also means there are new compliance considerations for entities receiving federal funds, especially as it relates to the False Claims Act’s “false certification” theory of liability ...
This paper will address the varying requirements for fair market value in transactions involving physicians and hospitals and other health care providers. The paper will first examine the Stark law and how and when transactions may satisfy Stark’s requirements for fair market value. Second, the use of fair market value for compliance with the federal Anti-Kickback statute will be addressed ...
The Act to Mitigate the Consequences of the COVID-19 Pandemic in Civil, Insolvency and Criminal Procedure Law (“COVID-19 Act”) provides for the option of online general meetings (“virtual general meetings”) for AGs [stock corporations], which numerous small and large stock corporations, including DAX-listed corporations, are already frequently using ...
Six months on from the implementation of sections 20 and 21 of the Road Safety Act 2006, and occupational road safety remains a significant cause for concern for employers. The Act introduced two new offences of causing death by careless driving and causing death whilst unlicensed, disqualified or uninsured, with offenders finding themselves facing up to five years’ imprisonment for what could be a momentary lapse of concentration ...
The Department of State (“DOS”) published in the Federal Register a Notice to implement the presidential initiative for extreme vetting of visa applicants. Emergency review of the DOS proposal has been requested from the Office of Management and Budget (“OMB”). The DOS has requested approval. If granted, the emergency approval would be valid for 180 days, although permanent approval could still be sought ...
Effective on April 6, 2020, an Order was published to establish the technical guidelines (the “Technical Guidelines”) for the activities described in Article 1, Section II, sub-sections (c) and (e) of the order that adopted extraordinary measures to deal with the health emergency caused by the SARS-CoV2 virus” (the “Order”). (We published an article on the Order, which may be foundhere ...
Regarding its functions, the UPME has been monitoring the demand for electrical energy and natural gas on a daily basis, in order to identify the impact of the measures taken to mitigate the effects of COVID-19 on the consumption of these energies. The following conclusions have been reached from this monitoring: Energy demand fell in April by 16.92% compared to the average scenario projected by the UPME and by 11.10% so far in May ...
The Costa Rica´s General Directorate of Customs issued the statement DGA-010-2020, which expands the list of products for surgical use that have export and re-export restrictions, which they had initially established through directive DGA-003-2020. The products added are as follows: Mono-glasses: Mono-glasses with indirect ventilation, transparent lens, foam covered frame and adjustable headband. Ergonomic and panoramic design. HSC: 9004.90.10.00 ...
