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 ...
The much-awaited relaxation of regulatory compliances under the Companies Act, 2013 (hereinafter “the Act”) have been introduced by the Ministry of Corporate Affairs (hereinafter “the MCA”). Please see below the detailed analysis of relaxations introduced by the MCA on regulatory compliances applicable under the Act: (i) Directors need not plan their Board meetings in the coming quarter of this calendar year i.e. upto June 30, 2020 ...
In an attempt to ensure that the spread of COVID-19 is contained effectively, the Indian Government has mandated a complete nationwide lockdown for 21 days beginning from March 25, 2020, 00:00 hrs. Mandatory Closure of Commercial Establishments All shops, commercial establishments, factories, workshops and offices, excluding establishments engaged in providing essential are required to be shut down ...
Employers have to face a number of issues in the current situation, some of which have data protection implications. Below you will find a brief summary of the data protection issues which are typically arising as a result of the pandemic, in a Q&A format.With regard to question no ...
This news alert includes information on the way in which the authorization for safe passage permits shall be granted on account of the nighttime curfew that stands in Chile as of the evening of this Sunday 22 March 2020, as an additional measure to face the Covid-19 pandemic: Individual safe-passage permit Collective safe-passage permit Permanent authorization for emergency personnel Authorization for companies and people who carry out transport of goods Airport Staff Passengers
Obligation of Czech employers to protect employees from coronavirusPursuant to Section 106 (1) of the Labour Code, an employee has the right be assured of occupational health and safety protection at work (hereinafter referred to as "OHS"), even during a pandemic.Regarding prevention, the provision in section 102 of the Labor Code remains paramount ...
Crisis measures issued after the announcement of the state of emergency List as of 14 March 2020 1. Temporary implementation of the protection of internal borders in the Czech Republic Underlying document: Government Declartion No. 197 from 12.3.2020 and extraordinary measures of the Ministry of the Interior dated 13.3.2020 Effectiveness from: 14.3.2020 od 0:00 hod. Effectivness until: 18.3 ...
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) ...
As a growing number of the workforce is being affected by the COVID-19 virus, employers are being asked to respond to benefit-related questions from employees. In the coming days, the Employee Benefits Group at Hanson Bridgett will be providing updated information on possible issues arising in the benefits area through Benefits Alerts and postings on Hanson Bridgett's Online COVID-19 Resource Center ...
Across the country, construction projects are being impacted by the on-set of the COVID-19 pandemic. The situation is dynamic and will change quickly. We thought it important to prepare some guidelines that would help firms navigate the situation from a risk management perspective. A one-size-fits-all solution does not exist, and this global challenge continues to evolve. What works today may not address tomorrow’s needs ...
A dynamic platform, gathering answers to your most frequently asked questions in relation to the ongoing crisis. The content of this page will be continuously updated based on the latest news. Click here to access the Arendt Covid-19 Solutions Platform ...
The global health alert triggered by the spread of the new coronavirus known as SARS-CoV-2, which causes the disease COVID-19, is creating great challenges for companies. Governments around the world are tackling the situation by approving drastic measures to try to mitigate the effects of the health crisis first and the economic crisis second ...
Dykema has launched a COVID-19 Resource Center to keep our clients up to date on the most recent legal, business and health guidance surrounding the novel coronavirus and how to navigate their businesses through uncertain times. Various firm practitioners are providing timely content that aims at providing guidance for employer’s current issues as well as those unforeseen items that have yet to arise ...
As of Monday, March 23, Virginia Governor Northam announced all public K-12 schools will remain closed through the end of the school year and many – but not all – non-essential businesses will be required to close their doors. By the end of Tuesday (11:59 p.m. on March 24) some non-essential services, including all recreation and entertainment services, are to close ...
A range of legislative and legal initiatives have been taken in recent days to control the spread of the SARS-CoV-2 coronavirus epidemic. How will temporary closing of borders and mandatory hospitalisation impact carriers’ liability in international transport of goods by road? Legal solutions adopted Faced with the SARS-CoV-2 coronavirus epidemic, the Polish government has decided to take drastic legal measures ...
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 Internal Revenue Service (“IRS”), the Department of Treasury, and the Department of Labor (“DOL”) recently issued preliminary guidance on the Families First Coronavirus Response Act (“FFCRA” or the “Act”) regarding (i) a temporary non-enforcement period during the first thirty (30) days of the Act; and (ii) more detail on how the employer payroll tax credit will work for the employer funding portion of the paid sick and child
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 ...
