Several state and local governments have issued “shelter in place” orders and undoubtedly more will follow. All have various exemptions for “essential businesses” and many rely on exemptions outlined in the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency (“CISA”) guidance on critical infrastructure workers ...
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 ...
FDA Warns Consumers About Unauthorized Fraudulent COVID-19 Products.The FDA issued a Consumer Update advising consumers to be beware of fraudulent coronavirus tests, vaccines and treatments. The FDA has seen unauthorized fraudulent test kits for COVID-19 being sold online. Currently, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19 ...
An article establishing a procedure for the procurement of medical supplies was recently introduced. This new provision (Resolution No 53960) amended Resolution No 38941-2006-JD of February of 2006, which is the general procurement regulation for the Social Security Administration (CSS for its initials in Spanish) ...
The FDA revised its guidance on postmarket adverse event reporting for medical products and dietary supplements during a pandemic to apply the guidance to the ongoing COVID-19 pandemic. The FDA acknowledges that companies, and the agency, itself, may be hit with workforce shortages during a pandemic at the same time that adverse event reporting for products deployed for the pandemic may increase ...
The U.S ...
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 ...
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 ...
The COVID-19 pandemic has disrupted every sector of the economy in multiple ways. For businesses whose operations are subject to environmental requirements, including waste management, storage, and disposal laws, these coronavirus-related disruptions may impact a facility’s ability to comply with mandatory reporting and submission deadlines or waste storage time limits ...
Regulators Expand Opportunities for Telehealth Services Under COVID-19 Shadow By: Phil Kim, Kayla Cristales, and Jennifer Kreick As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehealth services ...
As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehealth services.Telehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient’s health ...
As COVID-19 continues to spread, CMS has issued guidance to various healthcare providers, including, among others, home health agencies, nursing homes, and hospitals that are caring for the nation’s most at-risk patient populations.The guidance is intended to curb transmission and ensure healthcare providers have the information and resources necessary to respond to patient needs ...
On March 19, 2020 the Superintendence of Environment (“SOE”) issued the Exempt Resolution No. 497 (“Res. 497”), which is referred to a number of general instructions within the sanitary context caused by the coronavirus (COVID-19). I. Purpose. Carry out a permanent monitoring of the status of projects or activities and of the compliance with their applicable obligations given the current sanitary context. II. Recipients ...
The currently unstoppable strong spread of COVID-19 and the resulting restrictions on public life, such as quarantine measures and curfews, which are imposed in EU Member States and worldwide and which are sometimes very drastic, are also increasingly impairing the ability to work and communicate. In the meantime, various IP Offices have also reacted to this. 1 ...
At the end of February 2020, the Minister of Energy and Mineral Resources (MEMR) issued Regulation No. 4 of 2020 (Reg. 4/2020), as a second amendment to MEMR Regulation No. 50 of 2017 on the Use of Renewable Energy for the Provision of Electric Power which was initially amended through MEMR Regulation No. 53 of 2018 (“Reg. 50/2017”). Reg ...
In the advent of DNA testing, companies such as Ancestry.com and 23andMe have made it easy and convenient to submit DNA samples for testing from your own home. This type of genetic—also known as genomic—testing has been applied to a variety of uses, including paternity determinations and the discovery of genetic ancestors and relatives ...
With the Corona crisis, countries such as Germany, France and the Czech Republic have already announced bans on exports of protective gear to avoid shortages at their countries. But is this in conformity with the principle of free movement of goods as provided for in articles 34-36 TFEU? This principle is one of the cornerstones of the European Union's internal market which implies that national barriers to the free movement of goods within the EU need to be removed ...
Federal and state occupational safety and health regulations require employers to record and report certain work-related injuries and serious illnesses, including work-related fatalities and in-patient hospitalizations. While Cal/OSHA has stated that the common cold or flu are exempt from reporting and recording requirements, even if the employee became ill at work, this exemption does not apply to COVID-19 ...
In response to the outbreak of COVID-19, the Occupational Safety and Health Administration (OSHA) and the California Department of Occupational Safety and Health (Cal/OSHA) have issued guidance for employers. The guidelines provide guidance on how to determine if COVID-19 is a hazard in the workplace and employer obligations. Is COVID-19 a Workplace Hazard? Employers should determine if COVID-19 infection is a hazard in their workplace ...
The price of oil—already hammered by market conditions—took another stumble in the wake of the COVID-19 outbreak with no immediate relief in sight. Accordingly, the Oil & Gas Industry must prepare for the looming wave of oncoming legal issues, which will affect every sector of the market. This alert contains recommended actions for industry stakeholders ...
Companies, municipalities, and water systems must now report their per- and polyfluoroalkyl substances (PFAS) use to the federal government. A new federal law requires facilities using 100 pounds per year of a listed PFAS compound to self-report to the national Toxics Release Inventory (TRI). Monitoring and reporting requirements are often prerequisites to cleanup and enforcement, and this collection of data may be a bellwether for the future regulation of PFAS ...
On January 23, 2020, Law No. 21,202, which modifies various legal bodies in order to protect urban wetlands, entered into force with its publication in the Official Gazette. Object The Law seeks to protect urban wetlands declared by the Ministry of the Environment, either ex officio or at the request of the respective municipality ...
Long considered “emerging contaminants,” per- and polyfluoroalkyl substances (PFAS) have now emerged. And water agencies throughout California must take heed. As we last reported, in November 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) added two widely used PFAS compounds to the Proposition 65 list of chemicals known to cause reproductive toxicity: perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) ...
