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 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 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 ...
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 the world changes in the wake of the COVID-19 crisis, many employers will be forced to consider restructuring workforces, closing facilities and other employment-related options. But despite the unexpected nature of these difficult options, employers must nonetheless be aware of their notice requirements under the Worker Adjustment and Retraining Notification Act (WARN) and state mini-WARN acts ...
In light of the recent economic developments stemming from the COVID-19 pandemic, many employers are evaluating their employee benefit plans and how employee and employer costs will be impacted. The following summary provides a list of questions we have been receiving from clients over the past week, along with action items to help employers address these issues. Health and Welfare Plans and Fringe Benefits 1 ...
Several state and local governments have issued “shelter in place” orders and undoubtedly more will follow.All of them have various exemptions for “essential businesses” and many rely on these exemptions as 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 ...
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 ...
Late Tuesday night, the Department of Labor issued an official Frequently Asked Questions in regards to the recently passed Families First Coronavirus Response Act. READ NOW: Our complete Families First coverage Here are a few key takeaways: The effective date of the Act is April 1, 2020 ...
Employers are grappling with increasingly difficult decisions as COVID-19 changes our labor force and the ways we work in profound ways. Below are various benefits-related issues and solutions to consider, amidst a rapidly shifting legislative environment: 401(k) loans and hardship distributions:Most 401(k) plans allow in-service withdrawals in the event of financial hardship ...
On March 23, 2020, the Centers for Medicare & Medicaid Services (CMS) announced updates to its survey process in response to COVID-19 (press release,press release, andmemo). Specifically, as authorized pursuant to section 1135(b)(5) of the Social Security Act, CMS is prioritizing certain surveys and exercising enforcement discretion for all certified provider and supplier types for the next three weeks ...
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 ...
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 ...
It is, to say the least, an overwhelming time. On 16 March 2020, the government presented a proposal for support measures to companies and employees to mitigate the effects of the corona virus. The proposal was followed on 19 March 2020, by the bill “Additional Amending Budget due to the Corona Virus”. Read this article as a PDF here ...
