The Minister of Health is issuing successive anti-export lists covering an increasingly wide catalogue of products at risk of shortages. This is to ensure access to drugs and medical devices for patients in Poland, especially during the difficult time of the COVID-19 pandemic ...
The United States Trade Representative (USTR) announced a period for public comment on excluding medical goods from Section 301 China tariffs if they are needed to fight the coronavirus pandemic. The USTR notice was published in the Federal Register on March 25, 2020. The USTR previously granted approximately 200 exclusions from Section 301 tariffs for medical goods because they are needed to fight the COVID-19 pandemic. The U.S ...
With the onset of COVID-19, certain areas of academic and government-fueled research are exploding. However, universities and governments at all levels are also scaling down nonessential research tasks and limiting the enrollment of essential new human subjects or new animal experiments.[1] Similarly, private companies may be suspending or cancelling their research projects in an attempt to conserve financial resources and accommodate researchers working from home ...
On March 27, 2020, Congress passed the Coronavirus Aid, Relief and Economic Security (CARES) Act. The $2 trillion bipartisan legislation serves as a third round of federal government support in the wake of the economic fallout from the coronavirus (COVID-19) pandemic. Among other things, the Act provides significant relief to air carriers and aviation employees. We outline some of the key provisions below ...
The identification of the food and drink sector as key in the response to the COVID-19 (C19) crisis seems obvious and unquestionable. Scratch the surface though and questions emerge, perhaps unsurprisingly because of the haste with which the emergency legislation was passed. The starting point recognised in the Coronavirus Bill was that the food supply chain involved not just producers but also intermediaries ...
Covid-19 has had an impact on ongoing consumer contracts and their relations with suppliers. The rapid spread of the virus led the authorities to declare State of Disaster in the country, raising concern about the (i) fulfillment of consumer contracts of goods and services and (ii) an eventual price manipulation ...
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) ...
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 ...
Restaurateurs and their employees don’t need anything else to worry about these days. It is challenging enough to operate a restaurant in this time of quarantines, curbside and delivery-only options, and social distancing added to the attendant drops in revenue and worries about making sure employees are cared for. Maybe the absolute last thing any restaurant wants to focus on are food safety regulations such as the Food Safety Modernization Act (FSMA) ...
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 ...
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 ...
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 ...
Will the need to seek state aid due to the COVID-19 pandemic encourage sports unions to implement good governance principles? According to press reports, work is underway at the Ministry of Sport on abill to aid the sports sector, including financial support, as sport is one of the sectors hardest hit by the COVID-19 pandemic. Cancellation of league matches, events and tournaments is causing heavy losses for all participants in the sector ...
The 22 March Decree was anticipated by two ordinances issued on 21 March 2020 by, respectively, the Lombardy Region1, subsequently amended on 22 March 2020 (the “Lombardy Ordinance”), and the Piedmont Region 2 (the “Piedmont Ordinance”). The ordinances provide for even more stringent restrictions for the regions concerned, and will remain in force until 3 April 2020 (for the Piedmont Region) and 15 April 2020 (for the Lombardy Region) ...
As of March 11, 2020 the World Health Organization declared COVID-19 as an international pandemic, which besides the unfortunate health implications, it will produce a wide range of legal and economic impacts and challenges ...
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 ...
Amidst continuing COVID-19 concerns, regulators issued certain waivers of HIPAA requirements and penalties as well as additional guidance applicable during this public health emergency. HIPAA Enforcement Discretion for Telehealth ...
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 ...
On March 18, 2020, Governor Jim Justice suspended the rule prohibiting bars and restaurants from providing beer and wine for off-premises consumption. Restaurants and bars with Class A licenses are now permitted to sell sealed bottles or cans of beer in their original containers and bottles of wine to-go so long as they are accompanied by food orders. The rule does not authorize the sale of beer growlers unless the individual possesses a beer growler license ...
