Morgan Lewis has long recognized the importance of employing a strategic, business-focused approach to addressing client matters. That has never been as important as right now, when companies across all industries are looking for practical guidance on ways to protect their businesses and their people. Our cross-disciplinary teams take a comprehensive approach to understanding our clients’ industry-based needs, providing a deep well of resources across broad sectors: energy, financial services, healthcare, life sciences, and retail and ecommerce.
States and localities across the country are continuing to respond as quickly and effectively as possible to the coronavirus (COVID-19) outbreak. These responses include guidance for taxpayers on numerous topics, such as providing tax relief through filing and payment deadline extensions.
A new coronavirus (COVID-19) relief bill—the Consolidated Appropriations Act, 2021, which includes the Taxpayer Certainty and Disaster Tax Relief Act of 2020 (the Act)—was signed into law on December 27. The Act not only contains tax provisions to provide direct relief to individuals, but also includes tax benefits for various industries, including the “green” energy and technology industries.
The Commodity Futures Trading Commission (CFTC) recently issued an interim report by CFTC Staff on the April 2020 price collapse of the West Texas Intermediate light sweet crude oil futures contract (WTI Futures Contract).
Partners Althea Day, Randall Tracht, and Johnathan Zimmerman authored a Pratt’s Energy Law Report article about the challenges energy companies face as they return to “normal” operations amid the coronavirus (COVID-19) pandemic.
Under the assumption that the coronavirus (COVID-19) public health emergency (PHE) will continue into 2021, the US Nuclear Regulatory Commission (NRC) Staff hosted a public meeting via teleconference on October 15 to discuss future requests for relief from regulatory requirements.
FERC has issued an order extending the blanket waivers of all requirements to hold meetings in person and/or to provide or obtain notarized documents in open-access transmission tariffs through January 29, 2021.
Our COVID-19 Legal Issue Compendium brings together in one place an overview of our key publications covering the legal and regulatory landscape, including matters related to business operations and industry-specific issues faced by many companies around the world amid the pandemic.
The CARES Act’s Paycheck Protection Program provides loans targeted to small businesses to help keep their workers employed during the coronavirus (COVID-19) pandemic, and offers loan forgiveness to borrowers maintaining a high percentage of employees on payroll. This LawFlash provides the latest developments in PPP loan availability, eligibility, and forgiveness, as well as a comprehensive overview of the PPP and related guidance.
The Department for Business, Energy & Industrial Strategy published a statement on 30 July announcing that furloughed employees will receive statutory redundancy pay based on their normal wages, rather than a reduced furlough rate.
The Federal Reserve took additional actions on April 9 to provide up to $2.3 trillion in loans to support the US economy during the coronavirus (COVID-19) pandemic. This LawFlash covers the new and expanded programs, and provides comprehensive coverage of the Coronavirus Economic Stabilization Act.
The UK Supreme Court issued a policyholder-friendly decision earlier this year on the Financial Conduct Authority’s business interruption test case. The judgment will apply to policyholders’ claims on a case-by-case basis.
States and localities across the country are continuing to respond as quickly and effectively as possible to the coronavirus (COVID-19) outbreak. These responses include guidance for taxpayers on numerous topics, such as providing tax relief through filing and payment deadline extensions.
Following the enactment of the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act in December 2020, the Biden administration announced several changes to the Paycheck Protection Program on February 22, 2021 aimed at providing greater access to funds for underserved businesses and communities. This LawFlash discusses these recent changes, highlighting key provisions and guidance for businesses seeking to participate in the program before it officially expires on March 31, 2021 (pending any additional legislation from Congress).
As part of President Joe Biden’s efforts to address the continuing impact of the COVID-19 pandemic on American families, on February 16, the US Department of Housing and Urban Development, US Department of Veterans Affairs, and US Department of Agriculture (together, the agencies) announced a coordinated extension and expansion of forbearance and foreclosure relief programs. This announcement extends and expands the agencies’ forbearance and foreclosure relief programs through June 30, 2021. The programs were due to expire in March.
Despite a strict prohibition on gatherings of more than two persons in any public place in Hong Kong through at least February 17, there is an exemption for shareholders’ meetings of companies listed on the Stock Exchange of Hong Kong, with certain conditions.
The US Congress has passed a spending bill that includes $285 billion to extend and expand the Paycheck Protection Program, providing new first-time loans and adding second-draw loans to help support small businesses. This LawFlash discusses the new stimulus package that is part of the Consolidated Appropriations Act, highlighting key provisions and guidance for businesses seeking to participate in the revived program.
Morgan Lewis partner Jeffrey Boujoukos spoke with Law360 for an article about the likely impact of the COVID-19 pandemic and a Biden administration on the US Securities and Exchange Commission’s (SEC’s) enforcement priorities.
The shock, turmoil, uncertainty, and lack of visibility that followed the immediate onset of the coronavirus (COVID-19) pandemic in March 2020 were significant factors accounting for why shareholder activism was relatively subdued during the 2020 proxy season. However, given that activist investors have now had more than eight months to acquire their “sea legs” and recalibrate their playbook for the evolving “new normal,” it is likely that, even as the COVID-19 pandemic shows no signs of abating, activist investors will be less reluctant to wage an activism campaign in whatever “new normal” we find ourselves in during the 2021 proxy season.
Nonprofit organizations are on the front lines in the battle against the coronavirus (COVID-19), but they also number among the many victims of COVID-19’s devastating financial impact. In response, the Federal Reserve recently announced that loans would be available to nonprofit borrowers under the Main Street Lending Program, and issued a FAQ on two new facilities—the Nonprofit Organization New Loan Facility and the Nonprofit Organization Expanded Loan Facility.
Morgan Lewis partners Matthew Schernecke and Kristen Campana authored a Bloomberg Law article about the concessions lenders have made in exchange for additional credit support, capital contributed, and/or additional covenants amid the coronavirus (COVID-19) pandemic.
The US Internal Revenue Service (IRS) issued news release IR-2020-194 on August 28, approving the temporary use of digital signatures for certain IRS forms that must be filed with the IRS manually.
The Centers for Disease Control and Prevention (CDC) on September 1 issued an order under Section 361 of the Public Health Service Act to temporarily—at least through the end of 2020—halt residential rental evictions for Americans struggling to pay rent due to the coronavirus (COVID-19) pandemic.
The Financial Conduct Authority (FCA) has challenged eight insurers in a business interruption insurance test case in order to seek coverage for insureds. The UK’s financial services industry regulator is taking an adversarial stance in order to determine whether 17 different policy wordings can provide cover for businesses across the country, in the hope this will provide a level of certainty at this difficult time for businesses.
As state revenue agencies train their auditors in traditional IRC §482 transfer-pricing methodologies or outsource transfer-pricing audits to third-party specialists, a recent initiative by the Indiana Department of Revenue follows another, alternative federal transfer-pricing compliance tool: advance pricing agreements (APAs).
Morgan Lewis partner Roger Joseph spoke with Fund Directions for an article about virtual board meetings amid the coronavirus (COVID-19) pandemic.
The coronavirus (COVID-19) pandemic has caused upheaval in the global economy. This massive disruption has led to a wave of class action lawsuits relating, directly or indirectly, to COVID-19. This White Paper reviews the various categories of such class actions, the most commonly asserted theories of liability, and possible defenses to such actions, both as to the merits and against class certification.
The US Securities and Exchange Commission’s Office of Compliance Inspections and Examinations (OCIE) published a Risk Alert on August 12 highlighting compliance considerations created by the coronavirus (COVID-19) pandemic for SEC-registered investment advisers and broker-dealers (Firms). This LawFlash highlights the areas of focus in the Risk Alert and provides a checklist of considerations and actions to assist Firms in addressing COVID-19-related compliance issues.
Our COVID-19 Legal Issue Compendium brings together in one place an overview of our key publications covering the legal and regulatory landscape, including matters related to business operations and industry-specific issues faced by many companies around the world amid the pandemic.
The CARES Act’s Paycheck Protection Program provides loans targeted to small businesses to help keep their workers employed during the coronavirus (COVID-19) pandemic, and offers loan forgiveness to borrowers maintaining a high percentage of employees on payroll. This LawFlash provides the latest developments in PPP loan availability, eligibility, and forgiveness, as well as a comprehensive overview of the PPP and related guidance.
As negotiations for a further comprehensive stimulus package drag on in Congress, US President Donald Trump on August 8 signed two executive actions—a combination of a memorandum and an executive order—that purportedly extend various aid measures previously provided through the Coronavirus Aid, Relief, and Economic Security (CARES) Act, or impose additional economic relief measures for homeowners, renters, and student loan borrowers impacted by the coronavirus (COVID-19) pandemic.
The Federal Financial Institutions Examination Council (FFIEC) on behalf of its members issued a statement on August 3 setting forth prudent risk management and consumer protection principles for financial institutions as initial coronavirus (COVID-19) related loan accommodation periods end and they consider additional accommodations.
The Federal Reserve took additional actions on April 9 to provide up to $2.3 trillion in loans to support the US economy during the coronavirus (COVID-19) pandemic. This LawFlash covers the new and expanded programs, and provides comprehensive coverage of the Coronavirus Economic Stabilization Act.
Although many companies are already revisiting contractual provisions relating to nonperformance, like force majeure clauses, as the coronavirus (COVID-19) pandemic continues to wreak havoc on public health and the economy.
The Consumer Financial Protection Bureau (CFPB or Bureau) issued an interim final rule (IFR) on June 23, 2020 that temporarily permits mortgage servicers to offer to borrowers impacted by the coronavirus (COVID-19) pandemic certain loss mitigation options based on the evaluation of an incomplete loss mitigation application.
The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of Health and Human Services (HHS) on January 31, 2020, and subsequently renewed several times, provided the basis for numerous flexibilities upon which the healthcare and life sciences industries have relied to furnish patient care during the pandemic. With the PHE coming to an end, organizations may need to make drastic changes as the regulatory enforcement returns to “normal.”
Key provisions that provided flexibility to long-term care providers and helped alleviate administrative burdens will expire May 11, 2023.
President Biden signed into law a House bill on April 10 that immediately ended the COVID-19 presidential declaration of national emergency established in March 2020. The COVID-19 federal public health emergency—a separate declaration by the Secretary of Health and Human Services from January 2020—remains in effect for now. However, based on comments from the Biden administration, that too is set to expire on May 11. As such, employers may wish to take stock of their COVID-19 policies and reevaluate those that touch on benefits, vaccine and testing requirements, and other safety measures.
Concurrent with the termination of the COVID-19 Public Health Emergency, various regulatory flexibilities will also come to an end, including the blanket waivers to the Stark Law and related enforcement discretion under the Federal anti-kickback statute. Accordingly, healthcare providers should promptly assess the ongoing compliance of all financial arrangements with physicians relying on these regulatory flexibilities and remediate or terminate such arrangements as appropriate.
The US Food and Drug Administration has finalized the framework for transitioning medical devices previously granted emergency use authorization or subject to particular enforcement policies to obtaining permanent marketing authorization.
With the COVID-19 public health emergency and the presidential declaration of national emergency intended to end on May 11 and the US government recently issuing guidance on unwinding these emergency declarations, this LawFlash breaks down the relief tied to each declaration and the next steps for plan sponsors.
Is the COVID-19 pandemic making you feel a bit like Bill Murray in Groundhog Day? Although most parts of life have returned to the "new normal," the federal government remains in a seemingly endless cycle of regulatory uncertainty.
According to a recent report from the Department of Health and Human Services, since the start of the pandemic sweeping policy changes made by the Centers for Medicare and Medicaid Services have led to a surge in virtual doctor visits.
As the availability and variety of digital health tools continue to increase, evidence is also being presented that those tools are having a meaningful impact on health outcomes. In a recent blog post, members of our technology, outsourcing, and commercial transactions team dove into the findings of two reports, Digital Health Trends 2021: Innovation, Evidence, Regulation, and Adoption, offered by the IQVIA Institute for Human Data Science; and a report from the University of Michigan’s Institute for Healthcare Policy and Innovation’s Telehealth Research Incubator.
Members of our emerging business and technology team recently hosted a webinar on seed financing structures for digital health companies. The program, led by partner Benjamin David Novak and associate Jessica Lee, discussed the market trends in digital health company financings as well as the various deal structures frequently used in seed financings.
Our healthcare team recently launched a publication series highlighting the global impact of COVID-19 on healthcare transactions. Around the globe, the healthcare industry has faced similar issues from the unprecedented pandemic, prioritizing their operational response to COVID-19. Now, as countries begin to reopen, healthcare entities may refocus on planning for long-term transformation of their business models. In this series, we will explore how the pandemic impacted healthcare transactions in specific regions and what we can expect in a post-pandemic world.
The recent rollout of various COVID-19 vaccines has raised many questions around their availability, distribution, and requirements for employers and other groups, including essential insurance, liability, and enforcement considerations. Here we provide key legal and regulatory perspectives for those organizations providing access to the vaccines and/or mandating vaccination. Highlights include the state and federal laws providing protection to organizations during an outbreak of an infectious disease and what employers contemplating the administration of a closed point-of-delivery (POD) vaccination program need to know.
Partner Sharon Masling spoke to CNBC after the US Food and Drug Administration (FDA) approved Pfizer’s COVID-19 vaccine for children ages 12–15 years.
Given the significant push to vaccinate the public since the start of 2021, the increasing availability of vaccines, and the need to recruit additional personnel to administer vaccinations, the secretary of the US Department of Health and Human Services (HHS) has again amended its declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to accommodate some workforce barriers that had not been previously contemplated.
States and localities across the country are continuing to respond as quickly and effectively as possible to the coronavirus (COVID-19) outbreak. These responses include guidance for taxpayers on numerous topics, such as providing tax relief through filing and payment deadline extensions.
It’s now been over a year since the COVID-19 pandemic was declared a public health emergency, ushering in monumental changes for telehealth regulation. If you’ve been following Health Law Scan, we hope our updates have provided some clarity to the everchanging regulatory healthcare framework and the legal issues that can vary across payers, across states, and even across countries.
Our immigration team has been actively publishing resources as the Biden administration continues to make changes to existing immigration framework. These topics may be of importance to Health Law Scan readers, and we encourage you to access these publications below.
In a Law360 feature, Morgan Lewis partner Dennis Gucciardo and associate Jacob Harper highlighted some of the defining moments for the healthcare and life sciences industries in the year since the US government declared the COVID-19 pandemic of sufficient severity and magnitude to warrant an emergency declaration.
The US Department of Health and Human Services Office of Inspector General (OIG), the Department of Justice (DOJ), and other federal regulators have grown increasingly concerned about the use of telehealth technologies by perpetrators of various fraud schemes. While this is in part due to the meteoric rise in use of telehealth services during the past year and the need to quickly formalize permanent policy around the technology, the federal government’s concern extends well before the COVID-19 public health emergency (PHE).
With telehealth surging around the globe due to the COVID-19 pandemic, the UK National Health Service has released guidance that provides a set of good practice principles for third-party partners to follow.
In response to delayed EU shipments of certain COVID-19 vaccines to the European Union, the European Commission (Commission) passed on 29 January 2021 Regulation 2021/111 (Export Authorization Regulation) which is in force from 30 January 2021. The Commission intends for the Export Authorization Regulation to apply until at least 31 March 2021.
The US Department of Health and Human Services (HHS) announced on Friday, January 15, 2021, one month before the former reporting deadline, that it will push back the CARES Act Provider Relief Fund (PRF) reporting timeline due to the enactment of the Coronavirus Response and Relief Supplemental Appropriations Act of 2021 (the Act).
Our finance, corporate and business transactions, litigation, and tax teams recently published a LawFlash discussing the new coronavirus (COVID-19) relief stimulus package that is part of the Consolidated Appropriations Act, 2021 (CAA), highlighting key provisions and guidance for small businesses seeking to participate in the revived Paycheck Protection Program (PPP).
With coronavirus (COVID-19) vaccines on the horizon amid the surging pandemic, critical extensions expand the scope of liability immunity under the PREP Act.
Associate Jacob Harper spoke with Modern Healthcare about the need for congressional action as the coronavirus (COVID-19) pandemic continues to increase the use of telehealth services.
A LawFlash authored by Morgan Lewis partners Sharon Perley Masling and Kathy Sanzo, and associates Christopher Jaynes, and Maria Kalousi-Tatum was quoted in an EHS Today article about the potential for employers to establish policies related to a COVID-19 vaccine.
The US Department of Health and Human Services (HHS) issued two welcome announcements on October 22 relating to the CARES Act Relief Fund Provider Relief Fund (PRF). First, the agency expanded the pool of eligible recipients to “include provider applicants such as residential treatment facilities, chiropractors, and eye and vision providers that have not yet received Provider Relief Fund distributions.”
The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the Food and Drug Administration (FDA) would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking.
Our global healthcare industry team continues to highlight how regions around the world have quickly adapted to providing telehealth services following the coronavirus (COVID-19) pandemic.
Our COVID-19 Legal Issue Compendium brings together in one place an overview of our key publications covering the legal and regulatory landscape, including matters related to business operations and industry-specific issues faced by many companies around the world amid the pandemic.
During the coronavirus (COVID-19) pandemic, we have seen a dramatic shift from in-person visits to telehealth services around the globe, unveiling what may be the new normal for providing healthcare services.
The CARES Act’s Paycheck Protection Program provides loans targeted to small businesses to help keep their workers employed during the coronavirus (COVID-19) pandemic, and offers loan forgiveness to borrowers maintaining a high percentage of employees on payroll. This LawFlash provides the latest developments in PPP loan availability, eligibility, and forgiveness, as well as a comprehensive overview of the PPP and related guidance.
Imagine you are the primary caretaker for your 94-year-old terminally ill mother who lives in your home while under hospice care during the coronavirus (COVID-19) pandemic.
US President Donald Trump issued an executive order on August 3 that aims to expand telehealth access to Medicare beneficiaries beyond the coronavirus (COVID-19) public health emergency (PHE) period. The executive order focuses on rural healthcare providers in particular, noting the difficulties patients in rural areas face in obtaining accessible, high-quality healthcare services over the years.
The coronavirus (COVID-19) pandemic has created unforeseen and unavoidable circumstances within the healthcare industry that may provoke further crisis for hospitals, nursing homes, physicians, and other frontline healthcare providers in the form of potential liability claims for noncompliance with COVID-19 protocols or other standards.
The Federal Reserve took additional actions on April 9 to provide up to $2.3 trillion in loans to support the US economy during the coronavirus (COVID-19) pandemic. This LawFlash covers the new and expanded programs, and provides comprehensive coverage of the Coronavirus Economic Stabilization Act.
Morgan Lewis FDA lawyers authored a LawFlash on June 29 summarizing FDA’s drug and biologic coronavirus (COVID-19) guidances to date.
Morgan Lewis FDA, litigation, and healthcare lawyers authored a LawFlash outlining key issues that companies marketing products and services for coronavirus (COVID-19) should be aware of, including healthcare, FDA, clinical laboratory, product liability, and digital and telehealth laws and regulations.
As summarized in a July 17 LawFlash, FDA has resumed inspections of regulated domestic facilities using a new risk assessment rating system that takes into account the reopening phase of the applicable state, and county level COVID-19 statistics.
The Centers for Medicare and Medicaid Services (CMS) recently announced that it intends to resume both prepayment and postpayment medical reviews conducted by the Medicare Administrative Contractors, Supplemental Medical Review Contractors, and Recovery Audit Contractors, including those under the Targeted Probe and Educate program, on August 3, 2020.
Singapore’s telehealth sector is driven by the growing telemedicine industry, which has seen an increase in digital self-help options to consult medical doctors through online web-based applications. Telehealth providers in Singapore are mainly focused on providing remote telemedicine and/or on-demand house call services.
If a proposed bill by the California Senate is passed, parties to certain post-pandemic healthcare transactions involving private equity groups, hedge funds, healthcare systems, facilities, and provider groups would need to plan for and obtain regulatory approval from the California attorney general.
Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight, product liability, and digital health/telehealth regulation.
Much to the relief of the healthcare provider community, US Department of Health and Human Services (HHS) spokesperson Michael Caputo tweeted on Monday that HHS intended to extend the public health emergency that was declared earlier this year.
The UK Competition and Markets Authority on June 19 announced that it had opened investigations against four pharmacies and convenience stores in relation to suspected breaches of antitrust rules by charging excessive and unfair prices for hand sanitiser products during the coronavirus (COVID-19) pandemic, and on June 29 published an open letter warning pharmacists against price gouging, raising the possibility of additional investigations.
In two draft companion guidance documents, the US Food and Drug Administration (FDA) establishes a proposed framework for transitioning medical devices currently marketed under emergency use authorization (EUA) or enforcement policy guidance to permanent marketing authorization. The draft FDA guidance documents provide manufacturers a 180-day transition period to submit a marketing application and stress that they should submit permanent marketing authorizations prior to finalization of the guidance documents.
The recent rollout of various COVID-19 vaccines has raised many questions around their availability, distribution, and requirements for employers and other groups, including essential insurance, liability, and enforcement considerations. Here we provide key legal and regulatory perspectives for those organizations providing access to the vaccines and/or mandating vaccination. Highlights include the state and federal laws providing protection to organizations during an outbreak of an infectious disease and what employers contemplating the administration of a closed point-of-delivery (POD) vaccination program need to know.
The Biden-Harris administration announced on May 5 its intent to support a waiver on intellectual property protections on COVID-19 vaccines. The scope of any potential waiver is subject to further negotiation at the World Trade Organization (WTO). Any decision made at the WTO level requires a consensus among all of its 164 members.
States and localities across the country are continuing to respond as quickly and effectively as possible to the coronavirus (COVID-19) outbreak. These responses include guidance for taxpayers on numerous topics, such as providing tax relief through filing and payment deadline extensions.
In a Law360 feature, Morgan Lewis partner Dennis Gucciardo and associate Jacob Harper highlighted some of the defining moments for the healthcare and life sciences industries in the year since the US government declared the COVID-19 pandemic of sufficient severity and magnitude to warrant an emergency declaration.
In one of the last proposed notices from the US Department of Health and Human Services (HHS) under the Trump administration, HHS removed the 510(k) premarket notification requirement for seven types of gloves and proposed the same for 84 other devices ranging from gowns to ventilators.
In response to delayed EU shipments of certain COVID-19 vaccines to the European Union, the European Commission (Commission) passed on 29 January 2021 Regulation 2021/111 (Export Authorization Regulation) which is in force from 30 January 2021. The Commission intends for the Export Authorization Regulation to apply until at least 31 March 2021.
January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on manufacturing considerations for certain cellular and gene therapy products during the COVID-19 pandemic.
The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC home sample collection kit for COVID-19 testing, as well as additional prescription at-home tests and sample collection kits.
A LawFlash authored by Morgan Lewis partners Sharon Perley Masling and Kathy Sanzo, and associates Christopher Jaynes, and Maria Kalousi-Tatum was quoted in an EHS Today article about the potential for employers to establish policies related to a COVID-19 vaccine.
MedTech Dive featured comments from Morgan Lewis partner Dennis Gucciardo in an article about the US Department of Health and Human Services directive to the US Food and Drug Administration to review requests for emergency use authorization for COVID-19 laboratory developed tests "in a timely manner.”
The coronavirus (COVID-19) pandemic continues to impact the biopharmaceutical industry. In a recent guidance, Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency (the Guidance), FDA provides manufacturers a heads up on steps they should consider when resuming normal operations.
The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the Food and Drug Administration (FDA) would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking.
Morgan Lewis partner Michael Abernathy spoke with Business Insurance for an article about the pharmaceutical industry’s efforts to produce a COVID-19 vaccine.
Morgan Lewis partner Robert Hibbert and associate Maria Kalousi-Tatum authored a Food Safety Magazine article about the US Food and Drug Administration (FDA) and the US Department of Agriculture’s memorandum of understanding (MOU) intended to prevent potential disruptions to the food supply chain resulting from the COVID-19 pandemic.
Our COVID-19 Legal Issue Compendium brings together in one place an overview of our key publications covering the legal and regulatory landscape, including matters related to business operations and industry-specific issues faced by many companies around the world amid the pandemic.
Morgan Lewis partner Dennis Gucciardo spoke with MedTech Dive for an article about the COVID-19 pandemic’s impact on the US Food and Drug Administration’s enforcement efforts. In the piece, he discussed the potential for virtual inspections.
The CARES Act’s Paycheck Protection Program provides loans targeted to small businesses to help keep their workers employed during the coronavirus (COVID-19) pandemic, and offers loan forgiveness to borrowers maintaining a high percentage of employees on payroll. This LawFlash provides the latest developments in PPP loan availability, eligibility, and forgiveness, as well as a comprehensive overview of the PPP and related guidance.
The Federal Reserve took additional actions on April 9 to provide up to $2.3 trillion in loans to support the US economy during the coronavirus (COVID-19) pandemic. This LawFlash covers the new and expanded programs, and provides comprehensive coverage of the Coronavirus Economic Stabilization Act.
With the coronavirus (COVID-19) pandemic showing no signs of abating, many digital health developers have refocused their technical expertise to develop products for use in the pandemic, including software apps for COVID-19 screening and risk assessments, digital therapeutics, and remote patient monitoring systems.
As the coronavirus (COVID-19) pandemic resurges, PREP Act liability immunity continues to be critical for manufacturers and users of COVID-19 medical products.
The US Food and Drug Administration’s recent policy, issued in part due to the coronavirus (COVID-19) pandemic, also suspends enforcement of Direct Marking requirements for certain Class I, Class II, Class III, and life-supporting/life-sustaining devices.
Kathy Sanzo spoke with MedCity News regarding the Department of Health and Human Services’ Covid-19 vaccine development program, Operation Warp Speed, which aims to develop vaccines against the SARS-CoV-2 in the space of a year rather than the multiple years normally required
The US Food and Drug Administration (FDA) announced on July 10 that it will resume domestic inspections of regulated facilities and activities using a new risk assessment rating system.
A LawFlash authored by Morgan Lewis partners Kathy Sanzo and Jacqueline Berman was cited in a BioProcess International article about guidance recently issued by the US Food and Drug Administration (FDA) for firms developing vaccines against SARS-CoV-2. As noted by the publication, the LawFlash advised developers to track FDA’s COVID-19-related actions, “as additional guidance and modifications to existing guidances are likely to be issued as reopening plans are implemented.”
Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight, product liability, and digital health/telehealth regulation.
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders. Now, as states begin to reopen, FDA appears to be looking toward the future, specifically providing guidance on prospectively addressing the impact of COVID-19 on clinical trials and compliance with current Good Manufacturing Practices (cGMPs). Below we provide brief summaries of key points from FDA’s drug and biologic COVID-19 guidance to date.
Partner Daryl Landy co-authored an article for the Daily Journal regarding Cal/OSHA’s changing approach to the Emergency Temporary Standards (ETS) it has issued over the last year. The article highlights the inconsistency in the standards, which has created a “skeptical employer audience when it comes to future emergency standards.”
States and localities across the country are continuing to respond as quickly and effectively as possible to the coronavirus (COVID-19) outbreak. These responses include guidance for taxpayers on numerous topics, such as providing tax relief through filing and payment deadline extensions.
Morgan Lewis partner Lee Harding and associate Will Mallin co-authored an article for Employment Law Journal about a recent High Court judgement, which held that the UK government failed to extend health and safety protections to “limb b” workers.
Morgan Lewis partner Anne Marie Estevez was quoted by Law360 in an article about the effect of COVID-19 on the retail sector, especially heading into what was traditionally a busy holiday season.
The primary focus of many retailers in the near term will likely be on staying afloat and addressing their liquidity needs, the health and safety of their employees and customers, the overall health of their businesses, and how best to pivot their business models to adapt to shifting consumer preferences and expectations in the wake of the ongoing coronavirus (COVID-19) pandemic.
Reopening procedures for retailers in Russia focus on employee scheduling, social distancing and sanitary plans, and medical screening protocols.
While retailers in China have been permitted to reopen, required steps to do so include health and sanitation measures. Some local governments are also considering extending the weekend in order to stimulate consumption and promote economic recovery.
Key questions and issues facing the UK retail sector, an industry that has been acutely impacted by the coronavirus (COVID-19) pandemic, include mitigation strategies, reopening in line with government guidance, and future expected challenges.
Our COVID-19 Legal Issue Compendium brings together in one place an overview of our key publications covering the legal and regulatory landscape, including matters related to business operations and industry-specific issues faced by many companies around the world amid the pandemic.
The CARES Act’s Paycheck Protection Program provides loans targeted to small businesses to help keep their workers employed during the coronavirus (COVID-19) pandemic, and offers loan forgiveness to borrowers maintaining a high percentage of employees on payroll. This LawFlash provides the latest developments in PPP loan availability, eligibility, and forgiveness, as well as a comprehensive overview of the PPP and related guidance.
The Federal Reserve took additional actions on April 9 to provide up to $2.3 trillion in loans to support the US economy during the coronavirus (COVID-19) pandemic. This LawFlash covers the new and expanded programs, and provides comprehensive coverage of the Coronavirus Economic Stabilization Act.
The United Kingdom is starting to see a return of the workforce for nonessential retail, which reopened on June 15. Shortly thereafter, the prime minister announced further easing of lockdown restrictions as the United Kingdom begins the third stage of its plan. From July 4, pubs, restaurants, hairdressers, hotels, and other outdoor activities are able to reopen if they comply with new guidance. From July 13, beauticians, spas, and salons are able to reopen. The UK government has also launched a new scheme, “Eat Out to Help Out,” to help the restaurant industry, giving diners 50% (up to £10) off their bill if they eat in a registered cafe or restaurant on a Monday, Tuesday, or Wednesday during August. To facilitate the reopening of these retail stores, the well-established two-meter social distancing rule will change to “one meter plus.” This Retail Did You Know? explores the issues UK nonessential retailers face from an employment perspective.
On July 1, California Governor Gavin Newsom announced closures of indoor dining and entertainment venues, as well as all bars, in 19 counties. California immediately issued Guidance describing these closures. Gov. Newsom also announced coordinated enforcement efforts, including the creation of Enforcement Strike Teams between state agencies and local counties and cities. Businesses are advised to regularly review the rules that remain in constant flux.
Morgan Lewis partners Leni Battaglia, Gregory Parks, and Melissa Rodriguez authored a Chain Store Age article about the impact of COVID-19 on luxury retail brands and best practices for reopening and continuing business. In the piece, they discuss how convincing retailers it’s safe to start shopping will be key to recovery.
The UK Competition and Markets Authority on June 19 announced that it had opened investigations against four pharmacies and convenience stores in relation to suspected breaches of antitrust rules by charging excessive and unfair prices for hand sanitiser products during the coronavirus (COVID-19) pandemic, and on June 29 published an open letter warning pharmacists against price gouging, raising the possibility of additional investigations.
The sports industry was among the first to navigate the resumption of some sense of regular play amid the pandemic, but it was far from normal. That wasn’t necessarily a bad thing. As sports have routinely blazed a trail for others to follow, teams and franchises continued that streak, first testing and then improving on ways to protect their players and staff from COVID-19, all the while attracting new interest from investors and advancing the call for racial justice. Now as many stadiums reopen to full capacity, we take a look back at what lessons the sports industry is likely to carry forward for the rest of 2021.
States and localities across the country are continuing to respond as quickly and effectively as possible to the coronavirus (COVID-19) outbreak. These responses include guidance for taxpayers on numerous topics, such as providing tax relief through filing and payment deadline extensions.
A federal district court in California issued a series of orders to dismiss claims in a putative class action by Major League Baseball ticket purchasers against ticket sellers, sports teams, and the league.
President-elect Joseph Biden has indicated that he will make significant changes to the policies and practices of the prior administration that will impact the public and employers, including in the sports industry.
Our COVID-19 Legal Issue Compendium brings together in one place an overview of our key publications covering the legal and regulatory landscape, including matters related to business operations and industry-specific issues faced by many companies around the world amid the pandemic.
The CARES Act’s Paycheck Protection Program provides loans targeted to small businesses to help keep their workers employed during the coronavirus (COVID-19) pandemic, and offers loan forgiveness to borrowers maintaining a high percentage of employees on payroll. This LawFlash provides the latest developments in PPP loan availability, eligibility, and forgiveness, as well as a comprehensive overview of the PPP and related guidance.
The coronavirus (COVID-19) pandemic brought much of the world’s professional sport to a standstill during the first half of 2020. Set against the background of widespread border closures, there has been significant uncertainty with respect to the lawful movement of people. Here, we look at the options available for people working across the breadth of the sports sector who wish to visit or move to the United Kingdom.
The Federal Reserve took additional actions on April 9 to provide up to $2.3 trillion in loans to support the US economy during the coronavirus (COVID-19) pandemic. This LawFlash covers the new and expanded programs, and provides comprehensive coverage of the Coronavirus Economic Stabilization Act.
Morgan Lewis partner Louise Skinner and associate Elizabeth Polido authored a Bloomberg Law article about the best practices to protect the health and safety of players, staff, and fans as sports restart around the world amid the COVID-19 pandemic.
States and localities across the country are continuing to respond as quickly and effectively as possible to the coronavirus (COVID-19) outbreak. These responses include guidance for taxpayers on numerous topics, such as providing tax relief through filing and payment deadline extensions.
Cybersecurity has earned its place at the top of organizations’ risk concerns during the COVID-19 pandemic. Remote working, an array of communication solutions and hardware being used by organizations, and the accelerated leveraging of cloud-based outsourcing solutions have increased the chain of potential vulnerabilities to cyberattacks.
An annual survey found that the coronavirus (COVID-19) pandemic has influenced decisions made by state chief information officers (CIOs) in 2020 in all areas addressed by the survey. The 2020 State CIO Survey (the Survey) released by the National Association of State Chief Information Officers, Grant Thornton Public Sector LLC and CompTIA (Sponsoring Organizations) was conducted several weeks after the start of COVID-19 and includes the responses from 47 state and territory CIOs.
Information Services Group (ISG) reported that the global outsourcing industry is slowly recovering from the industry’s dip in performance during the second quarter of 2020 due to the coronavirus (COVID-19). Data measuring commercial outsourcing contracts with annual contract values (ACV) of $5 million or more show that third-quarter ACV for the global market rose 3% to $14.6 billion.
Our global healthcare industry team continues to highlight how regions around the world have quickly adapted to providing telehealth services following the coronavirus (COVID-19) pandemic.
Our COVID-19 Legal Issue Compendium brings together in one place an overview of our key publications covering the legal and regulatory landscape, including matters related to business operations and industry-specific issues faced by many companies around the world amid the pandemic.
Morgan Lewis associate Jacob Harper spoke with Bloomberg Law for an article about the current state of the telehealth industry amid the COVID-19 pandemic and what the future may hold for telehealth once the virus subsides. In the piece, Jake discussed some of the biggest barriers to telehealth access, such as location rules.
During the coronavirus (COVID-19) pandemic, we have seen a dramatic shift from in-person visits to telehealth services around the globe, unveiling what may be the new normal for providing healthcare services.
As companies adjusted to the “new normal” of coronavirus (COVID-19) restrictions, spending on cloud services has seen a boom.
The CARES Act’s Paycheck Protection Program provides loans targeted to small businesses to help keep their workers employed during the coronavirus (COVID-19) pandemic, and offers loan forgiveness to borrowers maintaining a high percentage of employees on payroll. This LawFlash provides the latest developments in PPP loan availability, eligibility, and forgiveness, as well as a comprehensive overview of the PPP and related guidance.
With the world in various states of lockdown, your organization’s online presence is more important than ever…even more so with official enforcement of CCPA beginning last month. It may be a good time to spend an afternoon reviewing and updating the legal boilerplate on your organization’s website. Here is what we recommend for a basic three-part review to get you started:
US President Donald Trump issued an executive order on August 3 that aims to expand telehealth access to Medicare beneficiaries beyond the coronavirus (COVID-19) public health emergency (PHE) period. The executive order focuses on rural healthcare providers in particular, noting the difficulties patients in rural areas face in obtaining accessible, high-quality healthcare services over the years.
Companies developing digital therapeutics, clinical decision support apps, and other digital health technologies for use in the coronavirus (COVID-19) pandemic should be mindful of FDA’s quickly evolving policies and guidance affecting such technologies. In our recent LawFlash, FDA Regulation of COVID-19 Apps, Digital Therapeutics, and other Digital Health Technologies, we examine recent FDA developments and their implications for companies in the digital health space.
The Federal Reserve took additional actions on April 9 to provide up to $2.3 trillion in loans to support the US economy during the coronavirus (COVID-19) pandemic. This LawFlash covers the new and expanded programs, and provides comprehensive coverage of the Coronavirus Economic Stabilization Act.
With the coronavirus (COVID-19) pandemic showing no signs of abating, many digital health developers have refocused their technical expertise to develop products for use in the pandemic, including software apps for COVID-19 screening and risk assessments, digital therapeutics, and remote patient monitoring systems.
Morgan Lewis managing partners Bill Nash and Ayman Klaleq were interviewed by LexisNexis for a special edition of the Lexis Middle East Law Alert magazine, which gives a round-up of legal, finance, and tax developments across the Middle East.