Here are select February 2013 rulings of the Supreme Court of the Philippines on civil law: Civil Code-Common Carrier; requisite before presumption of negligence arises; bill of lading; interpretation thereof; inherent nature of the subject shipment or its packaging as ground for exempting common carrier from liability; failure to prove negligence does not entitle claimant for damages ...
On July 22, 2020, the National Assembly approved, after a third debate, Draft Law No. 83 (the “Draft Law”), which regulates limited liability entrepreneurship companies (the “LLECs”) in Panama, and is now awaiting the signature (or veto) of the President of the Republic ...
On June 3, 2024, a divided three-judge panel of the United States Court of Appeals for the Eleventh Circuit ruled that an Atlanta hedge fund likely violated 42 U.S.C. § 1981—the federal prohibition on racial discrimination in public and private contracting—by operating a grant contest that awarded $20,000 grants to select small business owners, all of whom, by the contest’s express rules, had to be Black women ...
June 8, 2023 By: Stephanie Shea and Michael Flynn On June 6, 2023, the FDIC, FRB and OCC collectively issued a document entitled, “Interagency Guidance on Third-Party Relationships: Risk Management” (“2023 Guidance”). Prior to this, each of these agencies had issued separate guidance on third-party risk. This 2023 Guidance replaces those separate pieces on third-party risk ...
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 ...
On November 14th, the Securities and Exchange Commission (the "SEC") and the Department of Justice (the "DOJ") released their jointly developed "Resource Guide to the U.S. Foreign Corrupt Practices Act" (the "Guide"). Long awaited and much anticipated, the Guide brings together in a single, 120-page document the agencies’ interpretation of the FCPA and approach to enforcement activities ...
The Federal Communications Commission (FCC), at its open meeting on December 13, 2023, approved new rules under the Telephone Consumer Protection Act (TCPA) regarding texting that will alter the landscape of lead generation practices ...
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 ...
On the 10 May 2023, the FCA published its findings from its review into firms’ approaches to fair value assessments under the new Consumer Duty. In conducting its review, the FCA’s objective was to understand how firms in different sectors are implementing the price and value requirements, in a bid to ensure that the internal supervisory and regulatory approaches within the FCA reflect industry thinking ...
In its Primary Market Bulletin 49 (PMB 49) (published in May 2024), the UK Financial Conduct Authority (FCA) issues a reminder to premium listed companies incorporated in the UK of their continuing disclosure obligations under the Listing Rules (LR). FCA issues reminders to listed companies on disclosure obligations The reminders emerged following a thematic 2023 review (the review) looking at disclosures made pursuant to LR 9.4 and LR 13 ...
On 20 April 2022 the FCA published its final rules requiring the disclosure of data in relation to diversity on listed company boards and executive committees. Policy Statement On 20 April 2022, the FCA published its final rules requiring the disclosure of data in relation to diversity on listed company boards and executive committees. The rules will apply to financial years beginning on or after 1 April 2022, so the first reporting will be in 2023 ...
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 ...
The FCA has published the results of its culture and non financial misconduct survey. Here are some points to note. Key facts: The FCA surveyed regulated wholesale financial services firms asking questions about incidences of non-financial misconduct and the firm’s policies and procedures relating to firms’ culture ...
On 26 July, the UK Financial Conduct Authority (FCA) published two consultation papers, CP24/12 and CP 24/13 (together, the CPs), relating to the new regime for public offers and admissions to trading to replace the existing UK Prospectus Regulation. These proposals are part of a package of measures designed to strengthen the UK’s capital markets; promoting more efficient and effective capital raising for issuers and increasing investor opportunities ...
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) ...
