On March 27, 2020, President Donald Trump signed into law a $2 trillion emergency relief bill to ease the economic impact of coronavirus (COVID-19) and support response efforts. The CARES Act[1] included an allocation of $80 million in funding to the U.S. Food and Drug Administration (FDA) to continue its COVID-19 response efforts. The additional agency funding will be used, in part, for the development of medical countermeasures and vaccines ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Significant False Claims Act (FCA) developments in the courts during the latter part of 2022 have included the Supreme Court’s declining to take up one issue involving FCA qui tam actions (what level of pleading particularity Rule 9(b) requires) while holding argument on another (the scope of the government’s dismissal power following declination), and the D.C. Circuit’s adoption of the pro tanto rule in computing settlement offsets in multiple-defendant cases ...
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) ...
Guided by the materiality standard from Escobar, a key safeguard for FCA defendants, the Western District of Pennsylvania found the Zaldonis relator failed to show the alleged fraud “would have any effect on the government’s decision to pay a claim.” Five years after the Supreme Court decided it, Escobar thus continues to set a high hurdle for plaintiffs ...
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 ...
General about enterprise penalty In relation to the previous section on enterprise penalty as enshrined in section 48a of the 1902 Penal Code, discussion were had as to whether there was a requirement of Fault-based liability in the provision. In the preparatory work on section 27 of the new Penal Code, this was discussed in depth, after which it in Ot.prp. no. 27, 90 (2003-2004) s. 242 was clearly stated that the new provision should not have such a requirement ...
I have recently been advising a farmer in relation to an appeal against a department penalty imposed for an alleged breach of GAEC (Good Agricultural Environmental Conditions). These are the conditions farmers claiming agricultural support payments must comply with, and which are designed to safeguard soils, habitats and landscape features on agricultural land. A breach of GAEC can lead to financial penalties being imposed on the farmer ...
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) ...
There are many famous cases where trademarks and passing off come into contact with unofficial merchandising and the right holder has been unsuccessful. They range from the fictional character Tarzan, to the rock band Linkin Park, to Diana Princess of Wales. There is no such thing as a matter of UK law as a free standing general right by a famous person (or anyone else) to control the reproduction of their image ...
There are many famous cases where trademarks and passing off come into contact with unofficial merchandising and the right holder has been unsuccessful. They range from the fictional character Tarzan, to the rock band Linkin Park, to Diana Princess of Wales. There is no such thing as a matter of UK law as a free standing general right by a famous person (or anyone else) to control the reproduction of their image ...
It is not uncommon to find parents continuing to pay an allowance to their children into adulthood, and in some cases this support continues post-marriage and can include payment of school fees or other financial provision being paid on a regular basis ...
This year, Family Mediation Week takes place between 17-21 January 2022. It exists to raise awareness of the benefits of family mediation and how the process can help separating families resolve their issues productively and collaboratively. The campaign is organised by the Family Mediation Council and is supported by Resolution ...
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 ...
