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) ...
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 ...
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 ...
I. Regulation In the context of the declaration of a State of Catastrophe, the National Customs Service (“NCS”) issued Exempt Resolution No. 1,179 dated March 18, 2020, by means of which the NCS adopted 13 measures to facilitate foreign and domestic trade operations electronically, and to protect the health of people involved in such operations ...
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 ...
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 ...
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 ...
1) Publish, circulate, and implement the latest CDC, local health department, and OSHA pronouncements on maintaining a healthy worksite and make sure you are stocked on essential product (soaps and sanitizers). 2) If you plan on allowing essential vendors and other visitors to continue coming onto your property, implement a visitor policy that: Requires visitors to acknowledge they have not come into contact with anyone at risk ...
The IRS has issued the several news releases in response to the COVID-19 pandemic: IRS Notice 2020-18 Tax Day now July 15. Treasury, IRS extend filing deadline and federal tax payments regardless of amount. The Treasury Department and IRS announced the federal income tax filing due date (for individual, trusts, estates, partnerships, corporations, and associations) is automatically extended from April 15, 2020, to July 15, 2020 ...
Special Report "COVID-19 in Central America" on special measures taken in each country of our region prepared by the multidisciplinary team of Consortium. The information contained in this publication is for information purposes only and does not constitute legal advice. The information is constantly updated and issubject to change. Last update: Wednesday 1 April ...
At LEĜA we are monitoring the measures that are taken to face the crisis generated by COVID-19 and we will be sending updates to our reports and comments divided by practice areas and industry so that you can easily find the information that is relevant to you. Please note that it is our policy to report announced measures only when they are translated into acts published in the Official Gazette ...
We have been in the UAE helping clients manage and survive crises for 45 years, and these are unprecedented times in our lives. We will have to work together to overcome the challenges brought about by the COVID-19 pandemic, and we at Afridi & Angell are ready to do our part. Until the end of March, we will offer free advice on legal issues affecting companies and employers as a result of the COVID-19 pandemic ...
The Republic of Serbia has officially closed its border crossings for passengers in road, rail, air and water traffic at 8.00 a.m. on 20 March 2020. The passing of humanitarian aid and crossings of national importance that are approved by the competent authority are still allowed. International passenger traffic to and from the Nikola Tesla Airport has been suspended in accordance with the Government of Serbia’s decision on 19 March 2020 from 12.00 p.m. onwards ...
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 ...
On March 23, 2020, in order to curb the spread of COVID-19 in Michigan, Governor Whitmer issued Executive Order 2020-21 (“EO 2020-21”), which orders all Michigan residents to stay at home or in their place of residence unless exempted until April 13, 2020, at 11:59 p.m. To this end, EO 2020-21 also orders that no person or entity may conduct a business or conduct operations that require workers to leave their homes or residences unless that entity qualifies for an exemption ...
