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 ...
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 ...
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 ...
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 ...
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 ...
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) ...
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 ...
On 11 January 2024 the Financial Conduct Authority (“FCA”) published policy statement PS24/1 (without consultation). The policy statement sets out temporary changes to the complaints handling rules for motor finance complaints, amid a rise in complaints against motor finance firms relating to commission ...
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) ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Last week, the U.S. Food and Drug Administration (FDA) issued guidance for the health care industry, titled “Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency ...
On April 6, the Food and Drug Administration (FDA) issued five warning letters chastising companies for their unapproved products related to the novel coronavirus disease 2019 (COVID-19). Two days later, the FDA issued another four warning letters for similar reasons. Two of the five warning letters issued on April 6 were issued to companies in connection with their CBD products, and one of the warning letters issued on April 8 was issued to a CBD company as well ...
Key Points A new FDA rule clarifies when food manufacturers may label fermented or hydrolyzed foods as gluten-free. Manufacturers making gluten-free claims must maintain records showing that the foods or food ingredients used in the foods are gluten-free prior to fermentation or hydrolysis. A product marked as gluten-free may be deemed misbranded under the Food, Drug, and Cosmetics Act if its manufacturer does not maintain supporting documentation to the satisfaction of the FDA ...
The Food and Drug Administration (“FDA”) issued its Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry on June 30, 2020. This nonbinding guidance is intended to remain in effect for the duration of the COVID-19 public health emergency declared by the Secretary of Health and Human Services. The guidance advises vaccine development and licensure following the standard trial progression but on an accelerated timeline ...
FDA announced it will open a public docket and hold an Immunology Devices Panel meeting to deliberate the potential for patients who receive medical device implants that contain select metal or metal alloys to develop immune and inflammatory reactions. The panel may provide input on scientific information the FDA should consider as part of premarket review and postmarket surveillance of metal-containing implants and dental amalgams ...
Acting Food and Drug Administration (FDA) Commissioner Norman Sharpless has issued a statement warning Americans to stop using vaping products that emit THC until further testing can be done. Federal and state public health agencies, including the FDA, have been investigating an unprecedented wave of 1,000-plus cases of severe lung injuries and deaths among consumers who claimed they used vaping products containing THC, nicotine, or both ...
Key Notes FDA announces flexible approach to enforcement of Nutrition and Supplement Facts labeling requirements for small food manufacturers and manufacturers of packaging for single-ingredient sugars, in part due to the impacts of COVID-19. The FDA adopted final rules updating the Nutrition and Supplement Facts1 labeling requirements (the “Rules”) that are effective on Jan ...
The U.S. Food and Drug Administration (FDA) recently issued a burst of COVID-19-related guidance documents to facilitate expanded availability of medical products during the current public health emergency created by COVID-19. FDA-regulated products under these temporary policies include: PPE, diagnostic tests, hand sanitizers, disinfectant devices, remote monitoring devices, ventilators, and electronic thermometers for clinical use ...
