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(FDA) announced that it was re-evaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities ...
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 ...
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 ...
In May 2016, the Division of Corporation Finance of the Securities and Exchange Commission (“SEC”) added new Compliance & Disclosure Interpretations (“C&DIs”) to the existing catalog of C&DIs that addresses disclosures of“non-GAAP financial measures ...
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 ...
As part of its effort to eliminate the risk of taxpayer-funded bail-outs of European banks, the European Union undertook a new “bail-in” regime beginning on January 1, 2016, implementing rules which require banks and some other market participants in EU member states to write-down, cancel, convert into equity or otherwise modify certain unsecured liabilities if such steps are required to recapitalize the institution.To red the full alert, click here ...
Less than two days after an enforcement moratorium expired, U.S. and EU officials in transatlantic data transfer talks have reached a new “Privacy Shield” framework to replace the Safe Harbor regime struck down in the Schrems case last year. The new framework, also known as Safe Harbor 2.0, is expected to increase obligations on U.S. companies that handle the personal data of Europeans, while bringing stronger privacy enforcement by the U.S. Federal Trade Commission (“FTC”) ...
ESG—environmental, social, and [corporate] governance—is the focus of socially responsible investing, reflecting the notion that corporations should serve the interests of not only their shareholders, but of all their stakeholders. This paper suggests NEPA’s EIS process provides a possible go-by for corporate decision-makers to use in ensuring that their ESG policies consider the big picture--the cons as well as the pros of their ESG policies ...
In the late 1980s, stories of garbage hauled in the same trucks regularly used to transport fruits and vegetables caused public outrage. Outbreaks of foodborne illnesses, including a salmonellosis outbreak that affected 224,000 consumers, have been attributed to contamination of transportation vehicles. Recently, a major U.S. foodservice distributor was penalized after its practice of storing seafood, milk and raw meat in unrefrigerated sheds was uncovered ...
On May 12th, EPA issued two rules that will significantly impact the oil and gas industry nationally. The first rule, an outgrowth of the President’s Climate Action Plan, establishes new source performance standards (“NSPS”) to curb emissions of methane, as well as volatile organic compounds (“VOCs”), from new natural gas and oil well sites and from new natural gas production gathering and boosting stations, processing plants, and transmission compressor stations ...
Responding to a Supreme Court mandate, the Environmental Protection Agency (“EPA” or “the Agency”) yesterday published a final supplemental finding that it is necessary and appropriate to regulate hazardous air pollutants emitted from coal- and oil-fired power plants under Section 112 of the Clean Air Act. 81 Fed. Reg. 24,420.Read the full alert ...
Many regulated entities are struggling to comply with certain environmental reporting, monitoring and settlement agreement requirements because of the impact of shelter in place orders, supply chain disruptions, and social distancing requirements relating to the COVID-19 pandemic response ...
Under English law, unlike civil law systems, a force majeure is neither defined nor automatically applicable to commercial contracts ...
Does the COVID-19 pandemic (or actions taken to counter the spread of COVID-19) constitute Force Majeure and is there any implied remedy (e.g. implied force majeure relief) arising as a result of the COVID-19 pandemic? Under English law, unlike civil law systems, force majeure is neither defined nor automatically applicable to commercial contracts ...
Does the Covid-19 pandemic (or actions taken to counter the spread of Covid-19) constitute a Force Majeure in a refit/ repair contract? Is there any implied right of relief for the contractor or the owner? Under English law, unlike civil law systems, a force majeure is neither defined nor automatically applicable to commercial contracts ...
2018 Summer Associate Molly Barham contributed to this alert. Two years ago, right after crude oil prices hit rock bottom in the middle of the worst downturn for U.S. producers since the 1980s, the Office of the Comptroller of the Currency (“OCC”) revised its Handbook for Examination of Oil and Gas Exploration and Production Lending (“E&P Handbook”) ...
The UKCS is the largest decommissioning market in the North Sea. There are around 475 fixed facilities, over 10,000 kilometres of pipeline and approximately 5,000 wells. These will all need to be decommissioned over the next 30 years, when they reach the end of their economic life, at an estimated cost of £59.7 billion ...
On March 18, 2020, President Trump signed into law the Families First Coronavirus Act that aims to provide emergency supplemental relief to Americans affected by the novel coronavirus (COVID-19) outbreak.The Act, among other things, aims to provide such relief by addressing three employment-related areas: (1) emergency paid sick leave to employees, (2) emergency leave under the Family and Medical Leave Act, and (3) support for unemployment insurance ...
In a landmark victory for employers, the Supreme Court of the United States held that agreements requiring employees to arbitrate claims on an individual basis are enforceable. The case,Epic Systems Corp. v. Lewis,1consolidated three different cases on appeal from the Fifth Circuit, Seventh Circuit and Ninth Circuit ...
In a landmark victory for employers, the Supreme Court of the United States held that agreements requiring employees to arbitrate claims on an individual basis are enforceable. The case, Epic Systems Corp. v. Lewis,1 consolidated three different cases on appeal from the Fifth Circuit, Seventh Circuit and Ninth Circuit ...
In its continuing efforts to slow the spread of COVID-19, on April 3, 2020, the Centers for Disease Control and Prevention (“CDC”) recommended that the general public wear, on a voluntary basis, “cloth face coverings in public settings where other social distancing measures are difficult to maintain (e.g., grocery stores and pharmacies) especially in areas of significant community-based transmission” of coronavirus ...
In February 2017, Secretary of Homeland Security John Kelly issued two memoranda providing guidance on the recent Executive Order entitled "Border Security and Immigration Enforcement Improvements." This Executive Order established new policies regarding effective border security and immigration enforcement ...
