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 ...
Seemingly overnight, flights and hotels emptied, and state and local governments began ordering restaurants, gyms, bars, and other “non-essential” businesses to close or to significantly curtail operations. Unemployment skyrocketed, and businesses began calling out for relief. In response, the government has proposed multiple initiatives to help stabilize businesses hit hard by current events, especially those in the hospitality industry, many of which are also franchises ...
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 ...
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 ...
In less than a week, SARS-CoV-2, the novel coronavirus that leads to COVID-19, has upended American lives and livelihoods.But while many are taking an unwanted break from business as usual, “essential businesses” are working overtime to rise to the critical call of keeping Americans healthy, safe, and fed while the nation shuts down and the virus spreads. First, each business must determine whether – and to what extent – it is essential ...
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 ...
The Centers for Medicare & Medicaid Services (CMS) announced during a March 19, 2020 teleconference for physicians and teaching hospitals that it does not have the authority to postpone the statutory timeline for the Physician Payments Sunshine Act (Sunshine Act) ...
The Centers for Disease Control (CDC) reports swimming is the fourth most popular recreational activity in the United States and the most popular recreational activity for children (ages 7 to 17). Statistics further show 36 percent of children and 15 percent of adults go swimming at least six times a year in the United States ...
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 ...
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 ...
According to press reports, most Germans are willing to accept limitations on the extent of the protection of their personal data vis-à-vis public authorities and agencies in order to tackle the coronavirus crisis. However, that alone is not an adequate justification for measures that employers may take during a coronavirus pandemic to prevent an outbreak in their company ...
The ongoing global COVID-19 pandemic is upending regular commercial activity across the United States and around the world, and that disruption is expected to escalate. Among the issues confronting our clients, the effect of public health orders and other measures to address COVID-19 is threatening, impacting, and in some cases, outright prohibiting the performance of material contractual obligations ...
At their core, the Regulations in terms of the Disaster Management Act, 2002 issued and brought into operation yesterday, 18 March 2020, outline the responsibilities of all government departments, the release and allocation of resources, and the conditions under which liquor industry may function. In the wake of the coronavirus (COVID-19) epidemic being declared a national state of disaster, the Regulations are intended to contain the spread of the virus ...
On March 18, 2020, the State Medical Board of Ohio (“Board”) held a special meeting, which resulted in the temporary suspension of certain regulatory enforcement activities in response to the COVID-19 pandemic. Telemedicine Effective immediately, the Board will suspend enforcement of any regulations requiring in-person visits between providers and patients ...
Introduction While the long-term litigation effects of the COVID-19 pandemic may not materialize for months – or even years – it is important for tort litigation attorneys and their clients to begin preparing now for potential legal issues that may arise. This bulletin is intended to serve as a non-exhaustive list of tort-focused legal considerations for health care providers, product manufacturers, and their attorneys in the new and ever-evolving COVID-19 landscape ...
In the early hours of Saturday, March 14, 2020, the United States House of Representatives passed the Families First Coronavirus Response Act (FFCRA), which is designed to expand relief in response to the COVID-19 outbreak, through access to free testing, enhancing food assistance, increasing Medicaid funding, and providing paid sick leave and unemployment benefits to workers ...
Ohio continues to be a leader in proactive restrictions to stop the spread of COVID-19 and securing the resources necessary to do so. On March 17, 2020, Ohio Governor Mike DeWine and Ohio Department of Health (ODH) Director Amy Acton, MD, MPH announced an ODH Order requiring the cancellation of all non-essential or elective surgeries or procedures that use personal protective equipment (PPE). This Order is effective at 5:00 p.m., Wednesday, March 18, 2020 ...
In order to limit the spread of COVID-19 and mitigate its effects, on 12 March 2020, the Government of the Republic of Estonia declared an emergency situation until 1 May 2020 and the Health Board recommends avoiding human contact. In this situation, implementing effective safety measures at the workplace often requires asking additional personal data, including health data from the employees ...
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 ...
