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 ...
On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule, which, if finalized, will allow an institutional review board (IRB) to waive or alter certain informed consent requirements if a clinical trial poses minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of those human subjects ...
To help prevent disruptions in the food supply-chain during the COVID-19 pandemic, the FDA issued a temporary policy for Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements. The policy states that the FDA will temporarily not enforce FSMA supplier verification onsite audit requirements if other appropriate supplier verification methods are used instead ...
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On May 28, 2013, the US Food and Drug Administration (FDA) published a draft guidance entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."1 The draft guidance describes FDA’s views on defining, establishing and documenting the responsibilities of parties that are involved in the contract manufacturing of drugs that are subject to current good manufacturing practice (cGMP) requirements ...
The FDA issued immediately-in-effect guidance to accelerate the development of certain laboratory tests for the urgent need caused by SARS-CoV-2. The FDA provides recommendations, among others, for serological tests, puts forth a policy for states to take responsibility for tests, and announces enforcement discretion for commercial manufacturers using new commercially developed tests prior to the FDA granting an emergency use authorization, under certain circumstances ...
FDA Takes Action to Increase U.S. Supplies in Response to COVID-19. The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices. The FDA is engaging the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S ...
More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was re-evaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities ...
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 ...
